FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K071174 |
ABBOTT SPINE, INC. |
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS |
07/25/2007 |
K082032 |
ABBOTT SPINE, INC. |
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) |
10/06/2008 |
K072672 |
ABBOTT SPINE, INC. |
SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES |
11/28/2007 |
K121568 |
ACCEL SPINE |
DALI SPINAL FIXATION SYSTEM |
09/21/2012 |
K140219 |
ACCEL SPINE |
PICASSO II MIS SPINAL SYSTEM |
04/14/2014 |
K120714 |
ACCEL SPINE |
PICASSO MIS SPINAL FIXATION SYSTEM |
08/09/2012 |
K062085 |
AESCULAP |
S4 SPINAL SYSTEM |
03/02/2007 |
K100147 |
AESCULAP IMPLANT SYSTEM, INC. |
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM |
07/23/2010 |
K130291 |
AESCULAP IMPLANT SYSTEM, INC. |
S4 SPINAL SYSTEM |
04/11/2013 |
K112551 |
AESCULAP IMPLANT SYSTEM, INC. |
S4 SPINAL SYSTEM |
11/21/2011 |
K100623 |
AESCULAP IMPLANT SYSTEMS |
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM |
06/09/2010 |
K090657 |
AESCULAP IMPLANT SYSTEMS |
MODIFICATION TO: S4 SPINAL SYSTEM |
04/20/2009 |
K071945 |
AESCULAP IMPLANT SYSTEMS |
S4 SPINAL SYSTEM |
09/20/2007 |
K083004 |
AESCULAP IMPLANT SYSTEMS, INC. |
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM |
07/02/2009 |
K123352 |
AESCULAP IMPLANT SYSTEMS, INC. |
S4 SPINAL SYSTEM |
12/12/2012 |
K123939 |
AESCULAP IMPLANT SYSTEMS, INC. |
S4 SPINAL SYSTEM |
03/12/2013 |
K162134 |
Aesculap Implant Systems, LLC |
ENNOVATE Spinal System |
12/14/2016 |
K180433 |
Aesculap Implant Systems, LLC |
ENNOVATE« |
04/26/2018 |
K062327 |
AESCULAP, INC. |
MODIFICATION TO S4 SPINAL SYSTEM |
03/14/2007 |
K062012 |
AESCULAP, INC. |
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM |
02/09/2007 |
K070460 |
ALLEZ SPINE, LLC |
ALLEZ SPINE CROSS CONNECTORS |
06/11/2007 |
K091219 |
ALLEZ SPINE, LLC |
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM |
07/09/2009 |
K051275 |
ALLEZ SPINE, LLC |
LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM |
12/09/2005 |
K072678 |
ALLEZ SPINE, LLC |
LAGUNA SIZE 8 PEDICLE SCREW |
07/02/2008 |
K091995 |
ALLEZ SPINE, LLC |
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM |
08/07/2009 |
K161363 |
ALPHATEC SPINE, INC |
Arsenal Spinal Fixation System |
06/10/2016 |
K152968 |
ALPHATEC SPINE, INC |
Arsenal Spinal Fixation System |
12/30/2015 |
K173522 |
Alphatec Spine, Inc |
Solanas« Posterior Stabilization System |
11/30/2017 |
K143149 |
ALPHATEC SPINE, INC. |
Arsenal Spinal Fixation System |
01/05/2015 |
K133221 |
ALPHATEC SPINE, INC. |
ARSENAL SPINAL FIXATION SYSTEM |
03/13/2014 |
K123623 |
ALPHATEC SPINE, INC. |
ILLICO MIS POSTERIOR FIXATION SYSTEM |
02/14/2013 |
K181677 |
Alphatec Spine, Inc. |
Kodiak Spinal Fixation System |
08/09/2018 |
K071380 |
ALPHATEC SPINE, INC. |
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM |
08/20/2007 |
K181980 |
Alphatec Spine, Inc. |
OsseoScrew System |
09/25/2018 |
K111076 |
ALPHATEC SPINE, INC. |
SOLANAS AVALON POSTERIOR FIXATION SYSTEM |
07/12/2011 |
K131119 |
ALPHATEC SPINE, INC. |
SOLANAS POSTERIOR STABILIZATION SYSTEM |
05/21/2013 |
K111634 |
ALPHATEC SPINE, INC. |
XENON(TM) PEDICLE SCREW SYSTEM |
01/25/2012 |
K181281 |
Altus Partners, LLC |
Altus Spine Pedicle Screw System |
06/11/2018 |
K181339 |
Altus Partners, LLC |
Altus Spine Pedicle Screw System |
07/24/2018 |
K151648 |
Altus Partners, LLC |
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System |
10/16/2015 |
K072022 |
AMEDICA CORP. |
VALEO PEDICLE SCREW SPINAL SYSTEM |
11/19/2007 |
K073430 |
AMEDICA CORP. |
VALEO PEDICLE SCREW SPINAL SYSTEM |
01/29/2008 |
K162160 |
AMEDICA CORPORATION |
Preference Elite Pedicle Screw System |
11/18/2016 |
K161842 |
Amendia, Inc. |
Overwatch Spine System |
10/13/2016 |
K132925 |
AMENDIA, INC. |
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK |
02/11/2014 |
K152920 |
AMENDIA, INC. |
Savannah-T« Pedicle Screw System |
07/08/2016 |
K153152 |
AMENDIA, INC. |
Syzygy Stabilization System |
04/27/2016 |
K141695 |
ARTHRO-DIF |
ACROSSPINE PEDICLE SCREW SYSTEM |
12/30/2014 |
K181139 |
Astura Medical, LLC |
OLYMPIC Posterior Spinal Fixation System |
07/06/2018 |
K182239 |
Astura Medical, LLC |
OLYMPIC Posterior Spinal Fixation System |
10/18/2018 |
K112759 |
ATLAS SPINE INC. |
APCLO PEDICLE SCREW SYSTEMS |
10/18/2011 |
K110842 |
ATLAS SPINE INC. |
ATLAS SPINE PEDICLE SCREW SYSTEM |
07/13/2011 |
K072426 |
ATLAS SPINE LLC |
ATLAS SPINE PEDICLE SCREW SYSTEM |
10/19/2007 |
K180301 |
Axis Orthopaedics |
AXIS 5.5 Lumbar Pedicle Screw System |
04/10/2018 |
K121786 |
B2B SPINE PTY LTD |
DYMAXEON SPINE SYSTEM |
11/05/2012 |
K150184 |
Back 2 Basics Direct, LLC |
Dymaxeon Spine System |
06/15/2015 |
K170989 |
Back 2 Basics Direct, LLC |
Dymaxeon Spine System |
05/22/2017 |
K161231 |
BAUI BIOTECH CO., LTD. |
FacilisÖ Spinal System |
01/23/2017 |
K133743 |
BAXANO SURGICAL, INC. |
BAXANO SURGICAL MIS SPINAL SYSTEM |
04/07/2014 |
K162232 |
Biedermann Motech GmbH & Co. KG |
MOSS 100 Pedicle Screw System |
11/17/2016 |
K181821 |
Biedermann Motech GmbH & Co. KG |
MOSS VRS Spinal System |
09/13/2018 |
K091067 |
BIOMET SPINE |
5.5 POLARIS SPINAL SYSTEM |
07/14/2009 |
K151974 |
BIOMET SPINE |
Polaris Spinal System |
11/13/2015 |
K121130 |
BIOMET SPINE |
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS |
06/15/2012 |
K081952 |
BIOMET SPINE |
SYNERGY SPINAL SYSTEM (6.35 POLARIS) |
10/07/2008 |
K133746 |
BIOMET SPINE (AKA EBI, LLC) |
POLARIS SPINAL SYSTEM |
03/12/2014 |
K123549 |
BIOMET SPINE (AKA EBI, LLC) |
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM |
02/25/2013 |
K123451 |
BIOMET SPINE (AKA EBI, LLC) |
POLARIS SPINAL SYSTEM - BALLISTA II RODS |
12/03/2012 |
K100409 |
BIOMET SPINE (AKA EBI, LLC) |
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM |
06/23/2010 |
K111957 |
BIOMET SPINE (EBI LLC) |
POLARIS SPINAL SYSTEM |
08/19/2011 |
K141804 |
BIOMET SPINE LLC, |
POLARIS SPINAL SYSTEM - HA COATED |
09/25/2014 |
K183080 |
BK Meditech Co., Ltd |
Mega Plus Spine System |
12/10/2018 |
K173180 |
BK MEDITECH Co., Ltd. |
Mega Plus Spine System |
03/15/2018 |
K182283 |
Black Box Medical |
FUSE Pedicle Screw System |
10/23/2018 |
K181554 |
Black Box Medical |
Stowe Pedicle Screw System |
07/27/2018 |
K100044 |
BLACKSTONE |
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY |
02/04/2010 |
K081684 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE PEDICLE SCREW SYSTEM |
09/15/2008 |
K082797 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE PEDICLE SCREW SYSTEM |
10/17/2008 |
K092624 |
BLACKSTONE MEDICAL, INC. |
FIREBIRD SPINAL FIXATION SYSTEM |
09/25/2009 |
K093926 |
BLACKSTONE MEDICAL, INC. |
FIREBIRD SPINAL FIXATION SYSTEM |
07/28/2010 |
K143110 |
BM KOREA |
GALAXY MIS Screw System |
06/24/2015 |
K133366 |
CAMBER SPINE |
ORTHROS POSTERIOR STABILIZATION SYSTEM |
04/08/2014 |
K180980 |
Camber Spine Technologies LLC |
ORTHROSÖ Posterior Stabilization System; ORTHROSÖ MIS Posterior Stabilization System |
10/27/2018 |
K180475 |
Captiva Spine, Inc. |
CapLOX II« / TowerLOX« MIS Pedicle Screw System |
03/19/2018 |
K182377 |
CarboFix Orthopedics Ltd. |
CarboClear« Pedicle Screw System |
09/27/2018 |
K181995 |
Chiral Surgical |
Chiral Surgical Pedicle Screw System |
09/20/2018 |
K132049 |
CHOICE SPINE |
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS |
08/15/2014 |
K171456 |
Choice Spine |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
08/03/2017 |
K160775 |
CHOICE SPINE LP |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
06/03/2016 |
K102204 |
CHOICE SPINE, LP |
CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM |
11/15/2010 |
K170821 |
Choice Spine, LP |
ChoiceSpineÖ Proliant« Posterior Pedicle Screw and Hook Fixation System |
06/08/2017 |
K170942 |
Choice Spine, LP |
The ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
04/26/2017 |
K120469 |
CLARIANCE |
ERISMA-LP |
08/13/2012 |
K162367 |
CLARIANCE SAS |
Erisma« LP MIS |
10/27/2016 |
K170163 |
CLARIANCE SAS |
Erisma« LP Spinal Fixation System |
02/14/2017 |
K153326 |
CLARIANCE, SAS |
Erisma-LP Spinal Fixation System |
03/08/2016 |
K182339 |
ClearView Orthopedic Development, LLC |
LEUCADIA AUTOLOKÖ Pedicle Screw System |
12/12/2018 |
K133369 |
CORELINK LLC |
TIGER SPINE SYSTEM |
01/14/2014 |
K121728 |
CORELINK LLC |
TIGER SPINE SYSTEM |
10/05/2012 |
K113058 |
CORELINK LLC |
TIGER SPINE SYSTEM |
03/29/2012 |
K131250 |
CORELINK LLC |
TIGER SPINE SYSTEM |
09/10/2013 |
K173185 |
CTL Medical Corporation |
SEURATÖ Universal Pedicle Screw System |
02/14/2018 |
K113361 |
CUMTOM SPINE |
SECURIS SPINAL FIXATION |
04/03/2012 |
K111099 |
CUSTOM SPINE, INC. |
ISSYS LP SPINAL FIXATION SYSTEM |
05/05/2011 |
K070281 |
CUSTOM SPINE, INC. |
ISSYS LP SPINAL FIXATION SYSTEM |
06/11/2007 |
K173814 |
Degen Medical |
DeGen Medical E3 MIS Pedicle Screw System |
01/29/2018 |
K160926 |
Degen Medical |
F1 MPS Modular Pedicle Screw System |
06/28/2016 |
K142531 |
Degen Medical |
F1-Modular Pedicle Screw System |
03/20/2015 |
K071495 |
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
EXPEDIUM 4.5MM SPINE SYSTEM |
06/29/2007 |
K102249 |
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
EXPEDIUM SPINE SYSTEM |
12/16/2010 |
K081252 |
DEPUY SPINE, INC. |
EXPEDIUM 4.5MM SPINE SYSTEM |
05/30/2008 |
K073364 |
DEPUY SPINE, INC. |
EXPEDIUM 4.5MM SPINE SYSTEM |
04/04/2008 |
K041801 |
DEPUY SPINE, INC. |
EXPEDIUM MIS SPINE SYSTEM |
09/08/2004 |
K090230 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM |
03/06/2009 |
K081898 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM |
09/10/2008 |
K063741 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM |
01/17/2007 |
K063772 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM |
07/10/2007 |
K073126 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM |
12/06/2007 |
K051024 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM |
07/06/2005 |
K070387 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM |
09/18/2007 |
K111136 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM |
06/14/2012 |
K110216 |
DEPUY SPINE, INC. |
EXPEDIUM SYSTEM, VIPER SYSTEM |
04/01/2011 |
K142185 |
DEPUY SPINE, INC. |
EXPEDIUM VERSE SPINE SYSTEM |
11/19/2014 |
K082942 |
DEPUY SPINE, INC. |
MODFICATION TO: EXPEDIUM SPINE SYSTEM |
10/31/2008 |
K080313 |
DEPUY SPINE, INC. |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
05/08/2008 |
K090799 |
DEPUY SPINE, INC. |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
04/22/2009 |
K063156 |
DEPUY SPINE, INC. |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
11/22/2006 |
K073562 |
DEPUY SPINE, INC. |
MODIFICATION TO VIPER SPINE SYSTEM |
05/15/2008 |
K092626 |
DEPUY SPINE, INC. |
MODIFICATION TO: EXPEDIUM SPINE SYSTEM |
09/25/2009 |
K071860 |
DEPUY SPINE, INC. |
MODIFICATION TO: VIPER SPINE SYSTEM |
08/01/2007 |
K101933 |
DEPUY SPINE, INC. |
MODIFICATION TO:EXPEDIUM SPINE SYSTEM |
10/18/2010 |
K082195 |
DEPUY SPINE, INC. |
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM |
09/03/2008 |
K103133 |
DEPUY SPINE, INC. |
VEPER SYSTEM, EXPEDIUM SYSTEM |
01/18/2011 |
K090648 |
DEPUY SPINE, INC. |
VIPER 2 SYSTEM |
06/10/2009 |
K102701 |
DEPUY SPINE, INC. |
VIPER SPINE SYSTEM |
10/20/2010 |
K061520 |
DEPUY SPINE, INC. |
VIPER SPINE SYSTEM |
06/23/2006 |
K121020 |
DEPUY SPINE, INC. |
VIPER SYSTEM |
05/03/2012 |
K101993 |
DEPUY SPINE, INC. |
VIPER SYSTEM, EXPEDIUM SYSTEM |
12/07/2010 |
K092473 |
DEPUY SPINE,INC |
EXPEDIUM SPINE SYSTEM |
11/25/2009 |
K033901 |
DEPUY SPINE,INC |
MERLIN SPINE SYSTEM |
03/31/2004 |
K090203 |
EBI, L.P. |
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS |
07/30/2009 |
K062685 |
EBI, L.P. |
EBI ARAY SPINAL SYSTEM |
10/06/2006 |
K042772 |
EBI, L.P. |
EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE |
12/13/2004 |
K061563 |
EBI, L.P. |
EBI ARRAY SPINAL SYSTEM |
06/23/2006 |
K031355 |
EBI, L.P. |
EBI SPINELINK - II SPINAL FIXATION SYSTEM |
07/22/2003 |
K031424 |
EBI, L.P. |
EBI SPINELINK SPINAL FIXATION SYSTEM |
07/22/2003 |
K033312 |
EBI, L.P. |
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM |
01/13/2004 |
K090523 |
EBI, L.P. |
POLARIS SPINAL SYSTEM |
07/01/2009 |
K100220 |
EBI, L.P. |
POLARIS SPINAL SYSTEM |
05/17/2010 |
K100438 |
EBI, L.P. |
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM |
06/23/2010 |
K140123 |
EBI, LLC |
POLARIS SPINAL SYSTEM -TRANSLATION SCREW |
04/24/2014 |
K142576 |
EISERTECH, LLC |
Spinal System |
02/26/2015 |
K070282 |
ENDIUS, INC. |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
09/06/2007 |
K073267 |
ENDIUS, INC. |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
01/30/2008 |
K060990 |
ENDIUS, INC. |
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM |
04/26/2006 |
K073510 |
ENDIUS, INC. |
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM |
02/11/2008 |
K072840 |
ENDIUS, INC. |
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM |
12/07/2007 |
K070367 |
ENDIUS, INC. |
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM |
04/12/2007 |
K080258 |
ENDIUS, INC. |
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
03/10/2008 |
K182478 |
Evolution Spine, LLC |
Whistler Modular Pedicle Screw System |
01/15/2019 |
K083825 |
EXPANDING ORTHOPEDICS, INC. |
EOI SPINAL SYSTEM |
03/19/2009 |
K160722 |
FACETLINK DBA LINKSPINE |
CorticaLINK Spinal Fusion Platform |
07/07/2016 |
K141850 |
FLOSPINE |
FLOSPINE PEDICLE SCREW SYSTEM |
10/27/2014 |
K161516 |
G SURGICAL LLC |
G Surgical Marksman MIS System |
08/25/2016 |
K173645 |
GBS Commonwealth Co., Ltd. |
JASPER Spinal Fixation System |
07/23/2018 |
K182059 |
GBS Commonwealth Co., Ltd. |
Prase MIS Spinal System |
10/04/2018 |
K161914 |
Genesys Spine |
Genesys Spine TiLock Cortical Spinal System |
08/09/2016 |
K103671 |
GENESYS SPINE |
GENESYS SPINE TILOCK SYSTEM |
07/21/2011 |
K152039 |
Genesys Spine |
Genesys Spine TiLock2 Spinal System |
10/28/2015 |
K172469 |
Genesys Spine |
TiLock Modular Spinal System |
11/30/2017 |
K100757 |
GENESYS SPINE |
TILOCK PEDICLE SCREW SYSTEM |
07/01/2010 |
K171838 |
Genesys Spine |
TiLock2 Spinal System |
07/19/2017 |
K133350 |
GLOBE MEDICAL, INC. |
REVERE STABILIZATION SYSTEM |
03/11/2014 |
K121922 |
GLOBUS MEDICAL INC. |
BEACON STABILIZATION SYSTEM |
07/26/2012 |
K073172 |
GLOBUS MEDICAL INC. |
BEACON STABILIZATION SYSTEM |
12/13/2007 |
K100788 |
GLOBUS MEDICAL INC. |
COCR RODS |
05/14/2010 |
K143633 |
GLOBUS MEDICAL INC. |
CREO Stabilization System |
01/30/2015 |
K180210 |
Globus Medical Inc. |
CREO« Stabilization System |
04/02/2018 |
K113395 |
GLOBUS MEDICAL INC. |
REVERE 4.5 STABILIZATION SYSTEM |
06/14/2012 |
K091782 |
GLOBUS MEDICAL INC. |
REVERE 6.35 STABILIZATION SYSTEM |
08/13/2009 |
K111479 |
GLOBUS MEDICAL INC. |
REVERE CROSSTOP |
08/17/2011 |
K093294 |
GLOBUS MEDICAL INC. |
REVERE STABILIZATION SYSTEM |
02/17/2010 |
K122226 |
GLOBUS MEDICAL INC. |
REVERE STABILIZATION SYSTEM |
10/01/2012 |
K061202 |
GLOBUS MEDICAL INC. |
REVERE STABILIZATION SYSTEM |
07/20/2006 |
K081195 |
GLOBUS MEDICAL INC. |
REVERE UNIPLANAR SCREWS |
05/28/2008 |
K110280 |
GLOBUS MEDICAL INC. |
REVLOK FENESTRATED SCREW SYSTEM |
07/06/2011 |
K073517 |
GLOBUS MEDICAL, INC. |
H-LINK INTEGRATED ROD |
01/03/2008 |
K092610 |
GLOBUS MEDICAL, INC. |
MODIFICATION TO BEACON STABILIZATION SYSTEM |
09/24/2009 |
K042953 |
GLOBUS MEDICAL, INC. |
MODIFICATION TO PROTEX STABILIZATION SYSTEM |
11/22/2004 |
K103072 |
GLOBUS MEDICAL, INC. |
REVERE SACRAL PLATES |
03/17/2011 |
K111449 |
GLOBUS MEDICAL, INC. |
REVOLVE ADDITIONAL IMPLANTS |
08/17/2011 |
K083416 |
GLOBUS MEDICAL, INC. |
REVOLVE STABILIZATION SYSTEM |
01/09/2009 |
K180626 |
Gm Dos Reis Industria E Comerico Ltda |
Pedimax II - Pedicular Screw Spinal System |
02/01/2019 |
K163096 |
GPC MEDICAL LIMITED |
GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System |
03/31/2017 |
K091717 |
GS MEDICAL CO., LTD. |
ANY PLUS SPINAL FIXATION SYSTEM |
01/25/2010 |
K172546 |
GS Medical Co., Ltd. |
AnyPlus« Spinal Fixation System |
10/23/2017 |
K120564 |
HOGAN LOVELLS US LLP |
CALYPSO SYSTEM |
07/16/2012 |
K030369 |
HOWMEDICA OSTEONICS CORP. |
OPUS SPINAL SYSTEM |
08/08/2003 |
K173131 |
Huvexel Co., Ltd |
Rexious Spinal Fixation System |
12/08/2017 |
K151977 |
ICOTEC AG |
icotec Pedicle System |
04/12/2016 |
K143731 |
IMPLANET S.A. |
IMPLANET Spine System (ISS) |
04/14/2015 |
K162764 |
IMPLANET S.A. |
JAZZ FRAME SYSTEM |
01/19/2017 |
K160226 |
Implanet, S.A. |
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector |
05/18/2016 |
K173126 |
Ingenium Spine |
ArisstosÖ Spinal System |
12/05/2017 |
K102248 |
INNOVASIS, INC. |
EXCELLA II SPINAL SYSTEM MODEL EC2-00 |
10/07/2010 |
K140238 |
INNOVASIS, INC. |
EXCELLA III-D SPINAL DEFORMITY SYSTEM |
05/07/2014 |
K071921 |
INNOVASIS, INC. |
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) |
11/16/2007 |
K053276 |
INNOVATIVE SPINAL TECHNOLOGIES INC |
IST PEDICLE SCREW SYSTEM |
12/27/2005 |
K181584 |
Innovative Surgical Designs, Inc. |
Redi-Spine |
08/10/2018 |
K170710 |
Innovative Surgical Designs, Inc. |
True Spinal Fixation System |
07/14/2017 |
K171559 |
Innovative Surgical Designs, Inc. |
True Spinal Fixation System |
07/24/2017 |
K142939 |
INTELLIGENT IMPLANT SYSTEMS, LLC |
Revolution Spinal Fixation System |
01/13/2015 |
K160216 |
INTELLIGENT IMPLANT SYSTEMS, LLC |
Revolution Spinal Fixation System |
04/22/2016 |
K163056 |
Intelligent Implant Systems, LLC |
RevolutionÖ Spinal Fixation System |
02/24/2017 |
K110551 |
JOHNSON & JOHNSON |
EXPEDIUM SPINE SYSTEM |
10/26/2011 |
K103490 |
JOHNSON & JOHNSON |
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM |
02/17/2011 |
K111571 |
JOHNSON & JOHNSON |
VIPER SYSTEMS |
07/06/2011 |
K173508 |
K2M |
Everest Spinal System |
01/09/2018 |
K181188 |
K2M Inc. |
EVEREST Spinal System |
05/30/2018 |
K142360 |
K2M, Inc |
Everest Spinal System |
01/21/2015 |
K151216 |
K2M, Inc |
Everest Spinal System |
08/10/2015 |
K151727 |
K2M, INC |
Everest Spinal System |
09/17/2015 |
K143334 |
K2M, INC |
Range/Denali/Mesa Spinal System |
01/09/2015 |
K150325 |
K2M, Inc |
Range/Denali/Mesa Spinal System |
03/31/2015 |
K133402 |
K2M, INC. |
K2M MODULAR HOOKS |
07/30/2014 |
K180376 |
K2M, Inc. |
K2M Patient Specific Rods |
04/05/2018 |
K181119 |
K2M, Inc. |
Range (Denali and Mesa) Spinal Systems |
06/26/2018 |
K141147 |
K2M, INC. |
RANGE SPINAL SYSTEM |
06/03/2014 |
K133944 |
K2M, INC. |
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM |
03/21/2014 |
K171832 |
K2M, Inc. |
Range/Denali/Mesa Spinal System |
09/14/2017 |
K141873 |
K2M, INC. |
RANGE/MESA/DENALI SPINAL SYSTEM |
09/08/2014 |
K140765 |
K2M, INC. |
RANGE/MESA/DENALI SPINAL SYSTEM |
07/10/2014 |
K161369 |
K2M, Incorporated |
EVEREST Spinal System |
07/21/2016 |
K153031 |
K2M, Incorporated |
RANGE/DENALI/MESA Spinal System |
11/17/2015 |
K140529 |
K2M, LLC |
EVEREST SPINAL SYSTEM |
05/22/2014 |
K172808 |
Kalitec Direct, LLC |
CosmoLock Pedicle Screw System |
10/25/2017 |
K112643 |
L & K BIOMED CO., LTD |
FOCUS MIS SYSTEM |
01/04/2012 |
K120140 |
L&K BIOMED CO., LTD |
FOCUS SPINAL SYSTEM |
02/15/2012 |
K120270 |
L&K BIOMED CO., LTD |
VENUS SPINAL FIXATION SYSTEM |
03/26/2012 |
K183168 |
L&K Biomed Co., Ltd. |
OpenLoc-L Spinal Fixation System |
12/11/2018 |
K171813 |
L&K BIOMED Co., Ltd. |
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System |
07/13/2017 |
K161766 |
L&K BIOMED Co., Ltd. |
PathLoc-L MIS Spinal System |
08/22/2016 |
K183117 |
L&K Biomed Co., Ltd. |
PathLoc-L MIS Spinal System |
11/15/2018 |
K143363 |
L&K BIOMED Co., Ltd. |
VENUS Spinal Fixation System |
04/22/2015 |
K133063 |
LANTERNA MEDICAL TECHNOLOGIES |
SANTIS PEDICLE SCREW SYSTEM |
01/13/2014 |
K150507 |
LANTERNA MEDICAL TECHNOLOGIES |
Santis Pedicle Screw System |
04/03/2015 |
K113434 |
LANX, INC. |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
12/19/2011 |
K121940 |
LANX, INC. |
LANX SPINAL FIXATION SYSTEM |
08/02/2012 |
K122145 |
LANX, INC. |
LANX SPINAL FIXATION SYSTEM |
08/17/2012 |
K100935 |
LANX, INC. |
LANX SPINAL FIXATION SYSTEM |
08/06/2010 |
K121316 |
LANX, INC. |
LANX SPINAL FIZATION SYSTEM |
09/10/2012 |
K103237 |
LANX, INC. |
LANX SPINAL SYSTEM |
03/25/2011 |
K092536 |
LANX, INC. |
SPINAL FIXATION SYSTEM |
10/30/2009 |
K103040 |
LANX, LLC |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
02/08/2011 |
K120399 |
LANX, LLC |
LANX SPINAL FIXATION SYSTEM |
03/09/2012 |
K082592 |
LDR SPINE USA |
LDR SPINE EASYSPINE SYSTEM |
10/08/2008 |
K123134 |
LDR SPINE USA INC. |
EASYSPINE SYSTEM |
02/01/2013 |
K121103 |
LDR SPINE USA INC. |
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S |
08/24/2012 |
K070995 |
LIFE SPINE |
ARX-LINK CROSS CONNECTOR |
06/22/2007 |
K090320 |
LIFE SPINE |
CONQUEST SPINAL SYSTEM |
07/22/2009 |
K073480 |
LIFE SPINE |
LIFE SPINE CROSS CONNECTOR |
01/04/2008 |
K123373 |
LIFE SPINE |
NAUTILUS SPINAL SYSTEM |
03/06/2013 |
K111953 |
LIFE SPINE |
NAUTILUS SPINAL SYSTEM |
08/07/2012 |
K151196 |
LIFE SPINE, INC |
Nautilus Spinal System |
07/14/2015 |
K140457 |
LIFE SPINE, INC |
NAUTILUS SPINAL SYSTEM |
03/25/2014 |
K132760 |
LIFE SPINE, INC |
NAUTILUS SPINAL SYSTEM |
10/03/2013 |
K132866 |
LIFE SPINE, INC |
NAUTILUS SPINAL SYSTEM |
10/28/2013 |
K141222 |
LIFE SPINE, INC |
NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM |
02/12/2015 |
K111729 |
LIFE SPINE, INC |
PILOT SPINAL SYSTEM |
09/07/2011 |
K150390 |
LIFE SPINE, INC. |
Nautilus Spinal System |
03/16/2015 |
K133564 |
LIFE SPINE, LLC. |
MODIFICATION TO NAUTILUS SPINAL SYSTEM |
02/19/2014 |
K173484 |
LinkSPINE Inc |
CorticaLINK Spinal Fusion Platform |
12/11/2017 |
K110655 |
MAHE MEDICAL GMBH |
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM |
10/27/2011 |
K141988 |
MEDACTA INTERNATIONAL |
M.U.S.T PEDICLE SCREW SYSTEM |
08/19/2014 |
K141044 |
MEDACTA INTERNATIONAL |
M.U.S.T. EXTENSION |
08/18/2014 |
K132878 |
MEDACTA INTERNATIONAL |
M.U.S.T. EXTENSION |
12/18/2013 |
K153664 |
MEDACTA INTERNATIONAL |
M.U.S.T. Pedicle Screw System |
01/19/2016 |
K171758 |
Medacta International SA |
M.U.S.T. Combined Set Screws |
08/01/2017 |
K162061 |
MEDACTA INTERNATIONAL SA |
M.U.S.T. Pedicle Screw System |
10/21/2016 |
K171170 |
Medacta International SA |
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws |
05/25/2017 |
K162786 |
MEDICREA INTERNATIONAL S.A |
PASS LP Spinal System |
01/25/2017 |
K161627 |
MEDICREA INTERNATIONAL S.A. |
PASS LP Spinal System |
07/29/2016 |
K153413 |
MEDICREA INTERNATIONAL S.A. |
PASS LP Spinal System |
04/22/2016 |
K141398 |
MEDICREA INTERNATIONAL S.A. |
PASS LP SPINAL SYSTEM |
01/09/2015 |
K182240 |
Medicrea International S.A. |
PASS LP Spinal System |
10/17/2018 |
K160640 |
MEDICREA INTERNATIONAL S.A. |
PASS XS Spinal System |
09/23/2016 |
K113396 |
MEDOS INTERNATIONAL SARL |
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM |
02/08/2012 |
K101070 |
MEDOS INTERNATIONAL SARL |
EXPEDIUM SPINE SYSTEM |
08/31/2010 |
K130877 |
MEDOS INTERNATIONAL SARL |
EXPEDIUM SPINE SYSTEM |
06/20/2013 |
K160904 |
MEDOS INTERNATIONAL SARL |
Expedium Spine System, VIPER and VIPER 2 Systems |
07/01/2016 |
K173095 |
Medos International SARL |
VIPER PRIMEÖ Screws, VIPER PRIMEÖ Screws with Fenestrations, EXPEDIUM« Verse Screws with Fenestrations |
10/25/2017 |
K171570 |
Medos International, SARL |
Additional VIPER PRIMEÖ screws with fenestrations |
08/31/2017 |
K162912 |
MEDOS INTERNATIONAL, SARL |
VIPER PRIMEÖ additions to the VIPER« System |
12/08/2016 |
K170543 |
Medos International, SARL |
VIPER PRIMEÖ Screws with Fenestrations |
05/04/2017 |
K142847 |
MEDTRONIC SOFAMOR DANCK USA, INC. |
CD HORIZON Spinal System |
10/27/2014 |
K110070 |
MEDTRONIC SOFAMOR DANCK USA, INC. |
TSRH SPINAL SYSTEM |
06/08/2011 |
K032560 |
MEDTRONIC SOFAMOR DANEK |
ARROWHEAD SPINAL SYSTEM |
03/09/2004 |
K053101 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
01/05/2006 |
K053474 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
01/06/2006 |
K032033 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
09/12/2003 |
K060615 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
10/25/2006 |
K090390 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
05/15/2009 |
K111457 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
09/15/2011 |
K042790 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
11/04/2004 |
K042886 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
11/18/2004 |
K091442 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
07/15/2009 |
K091445 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
09/27/2010 |
K082236 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
10/10/2008 |
K123246 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPIRE Z SPINAL SYSTEM |
11/16/2012 |
K113529 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON VOYAGER SPINAL SYSTEM |
02/09/2012 |
K170679 |
Medtronic Sofamor Danek |
CD HORIZON« Spinal System, Medtronic Reusable Instruments for Use with the IPC« POWEREASE« System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION« and IPC« POWEREASE« Systems |
05/11/2017 |
K052609 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
10/21/2005 |
K060203 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
02/13/2006 |
K042962 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
12/14/2004 |
K043488 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
03/21/2005 |
K063417 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
01/18/2007 |
K072429 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO TSRH SPINAL SYSTEM |
09/28/2007 |
K050282 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO TSRH SPINAL SYSTEM |
02/18/2005 |
K052187 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
08/22/2005 |
K042167 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
09/08/2004 |
K043321 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
02/03/2005 |
K090740 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO: TSRH SPINAL SYSTEM |
08/14/2009 |
K052747 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO:CD HORIZON SPINAL SYSTEM |
10/28/2005 |
K063670 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM |
06/28/2007 |
K091797 |
MEDTRONIC SOFAMOR DANEK |
TSRH SPINAL SYSTEM |
04/30/2010 |
K052054 |
MEDTRONIC SOFAMOR DANEK |
TSRH SPINAL SYSTEM |
08/16/2005 |
K052144 |
MEDTRONIC SOFAMOR DANEK |
TSRH SPINAL SYSTEM |
08/31/2005 |
K110676 |
MEDTRONIC SOFAMOR DANEK |
TSRH SPINAL SYSTEM |
05/23/2011 |
K081080 |
MEDTRONIC SOFAMOR DANEK |
TSRH SPINAL SYSTEM |
11/21/2008 |
K103049 |
MEDTRONIC SOFAMOR DANEK |
TSRH SPINAL SYSTEM |
12/23/2010 |
K101772 |
MEDTRONIC SOFAMOR DANEK |
TSRH(R) SPINAL SYSTEM |
09/30/2010 |
K093434 |
MEDTRONIC SOFAMOR DANEK |
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM |
12/02/2009 |
K132111 |
MEDTRONIC SOFAMOR DANEK USA |
CD HORIZON SPINAL SYSTEM |
08/06/2013 |
K170347 |
Medtronic Sofamor Danek USA |
CD HORIZONÖ Fenestrated Screw Set |
04/04/2017 |
K143141 |
MEDTRONIC SOFAMOR DANEK USA, INC |
CD HORIZON Spinal System |
12/01/2014 |
K143569 |
MEDTRONIC SOFAMOR DANEK USA, INC |
CD HORIZON Spinal System |
02/12/2015 |
K150178 |
MEDTRONIC SOFAMOR DANEK USA, INC |
CD HORIZON SPINAL SYSTEM |
02/11/2015 |
K143375 |
MEDTRONIC SOFAMOR DANEK USA, INC |
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments |
02/13/2015 |
K162494 |
MEDTRONIC SOFAMOR DANEK USA, INC |
CD HORIZON« Spinal System |
10/04/2016 |
K111942 |
MEDTRONIC SOFAMOR DANEK USA, INC |
TSRH SPINAL SYSTEMS |
08/30/2011 |
K152248 |
Medtronic Sofamor Danek USA, Inc. |
CD HORIZON Spinal System |
11/05/2015 |
K113174 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
11/21/2011 |
K142591 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON Spinal System |
12/01/2014 |
K152457 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON Spinal System |
10/27/2015 |
K123809 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
02/22/2013 |
K121680 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
07/05/2012 |
K102555 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
11/17/2010 |
K130646 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
04/10/2013 |
K153589 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON Spinal System |
02/10/2016 |
K141494 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
08/06/2014 |
K141604 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
10/21/2014 |
K141605 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
07/14/2014 |
K132328 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
12/06/2013 |
K132471 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
10/08/2013 |
K122862 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
10/03/2012 |
K132639 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
11/25/2013 |
K051674 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
07/21/2005 |
K153463 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON Spinal System, IPC POWEREASE System |
12/30/2015 |
K143019 |
Medtronic Sofamor Danek USA, Inc. |
CD HORIZON Spinal System, IPC POWEREASE System |
04/08/2015 |
K153442 |
Medtronic Sofamor Danek USA, Inc. |
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATIO |
02/18/2016 |
K112555 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON(R) SPINAL SYSTEM |
09/27/2011 |
K173249 |
Medtronic Sofamor Danek USA, Inc. |
CD HORIZONÖ Spinal System |
03/08/2018 |
K182119 |
Medtronic Sofamor Danek USA, Inc. |
CD HORIZONÖ Spinal System |
08/29/2018 |
K162379 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON« Spinal System |
11/16/2016 |
K163301 |
Medtronic Sofamor Danek USA, Inc. |
CD HORIZON« Spinal System |
12/20/2016 |
K091974 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
09/02/2009 |
K101074 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM |
06/22/2010 |
K092325 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MODIFICATION TO:CD HORIZON SPINAL SYSTEM |
12/15/2009 |
K072317 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MODIFICATION TO:TSRH SPINAL SYSTEM |
09/18/2007 |
K062254 |
MEDTRONIC SOFAMOR DANEK, INC. |
AXIS FIXATION SYSTEM |
06/16/2008 |
K121764 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
08/21/2012 |
K102807 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
11/17/2010 |
K111510 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
09/15/2011 |
K140449 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
03/25/2014 |
K122433 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
09/28/2012 |
K112473 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
10/21/2011 |
K050439 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
03/24/2005 |
K063083 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
11/06/2006 |
K061592 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO CD HORIZON SYSTEM |
07/03/2006 |
K030285 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO TSRH SPINAL SYSTEM |
02/25/2003 |
K092676 |
MEDTRONIC SOFAMOR DANEK, INC. |
TSRH SPINAL SYSTEM |
10/02/2009 |
K093058 |
MEDTRONIC SOFAMOR DANEK, INC. |
TSRH SPINAL SYSTEM |
10/26/2009 |
K062807 |
MEDTRONIC SOFAMOR DANEK, INC. |
TSRH SPINAL SYSTEM |
11/06/2006 |
K121670 |
MEDYSSEY CO., LTD. |
MEDYSSEY CANNULATED PEDICLE SCREW |
01/25/2013 |
K142835 |
MEDYSSEY USA, INC. |
Iliad Pedicle Screw System and Zenius Pedicle Screw System |
06/12/2015 |
K171509 |
Medyssey USA, Inc. |
Iliad« Pedicle Screw System and Zenius« Pedicle Screw System |
06/12/2017 |
K131878 |
MEDYSSEY USA, INC. |
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM |
08/23/2013 |
K170964 |
Medyssey USA, Inc. |
Zenius Spinal System |
04/26/2017 |
K181978 |
Medyssey USA, Inc. |
ZeniusÖ, IliadÖ and KoraÖ Spinal Fixation Systems |
08/13/2018 |
K171526 |
Medyssey USA, Inc. |
ZeniusÖ, lliadÖ and KoraÖ Spinal Fixation Systems |
08/21/2017 |
K170108 |
Met One Technologies |
Xultan 5.5 Pedicle Screw System |
05/02/2017 |
K182970 |
MiRus, LLC |
EUROPAÖ Pedicle Screw System |
01/22/2019 |
K113173 |
NANOVIS, LLC |
NANOVIS SPINAL SYSTEM |
01/19/2012 |
K171582 |
Neo Medical S.A. |
NEO Pedicle Screw SystemÖ |
09/12/2017 |
K072116 |
NEUROSPINE INNOVATIONS AND SOLUTIONS |
SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM |
03/20/2008 |
K143230 |
Neurostructures, Inc. |
Palladian Lumbar Pedicle Screw System |
02/25/2015 |
K161499 |
NEXT ORTHOSURGICAL |
VertiForm Posterior Fixation System |
07/29/2016 |
K141291 |
NEXT ORTHOSURGICAL |
VERTIFORM POSTERIOR FIXATION SYSTEM |
08/26/2014 |
K160820 |
Nexus Spine, LLC |
PressON Pro Spinal Fixation System |
06/28/2016 |
K153453 |
NEXXT SPINE LLC |
Inertia Pedicle Screw and Deformity Correxxion System |
04/26/2016 |
K143684 |
NUVASIVE INCORPORATED |
NuVasive Reline System |
04/23/2015 |
K132014 |
NUVASIVE, INC. |
GSB GLOBAL SPINAL BALANCE SYSTEM |
10/31/2013 |
K083028 |
NUVASIVE, INC. |
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM |
11/13/2008 |
K090981 |
NUVASIVE, INC. |
MODIFICATION TO: NUVASIVE SPHERX SYSTEM |
07/02/2009 |
K121619 |
NUVASIVE, INC. |
NUVASIVE POLYAXIAL SPINAL SCREWS |
08/24/2012 |
K122352 |
NUVASIVE, INC. |
NUVASIVE PRECEPT SPINAL SYSTEM |
09/11/2012 |
K092287 |
NUVASIVE, INC. |
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM |
10/06/2009 |
K102514 |
NUVASIVE, INC. |
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM |
12/01/2010 |
K091502 |
NUVASIVE, INC. |
NUVASIVE SPHERX II SYSTEM |
07/22/2009 |
K082332 |
NUVASIVE, INC. |
NUVASIVE SPHERX SYSTEM |
10/10/2008 |
K142737 |
NUVASIVE, INCORPORATED |
MAS PLIF Fixation system |
12/18/2014 |
K171894 |
NuVasive, Incorporated |
NuVasive« PreceptÖ Spinal System |
09/28/2017 |
K170126 |
NUVASIVE, INCORPORATED |
NuVasive« Reline« 4.5-5.0 System |
03/09/2017 |
K160989 |
NuVasive, Incorporated |
NuVasive« Reline« System |
06/09/2016 |
K161014 |
NUVASIVE, INCORPORATED |
NuVasive« Reline« System |
09/28/2016 |
K142499 |
NUVASIVE, INCORPORATED |
Reline System |
11/19/2014 |
K180458 |
Nvision Biomedical Technologies, LLC |
FOCUS Pedicle Screw System |
04/17/2018 |
K163566 |
Orbbo Surgical, LLC. |
Hubble I System |
02/09/2017 |
K142146 |
ORTHO DEVELOPMENT CORP. |
IBIS PEDICLE SCREW SYSTEM |
12/11/2014 |
K131785 |
ORTHO DEVELOPMENT CORP. |
PAGODA PEDICLE SCREW SYSTEM |
08/20/2013 |
K162995 |
Ortho Development Corporation |
Ibis« Pedicle Screw System |
03/30/2017 |
K130176 |
ORTHOFIX |
FIREBIRD SPINAL FIXATION SYSTEM |
03/28/2013 |
K122901 |
ORTHOFIX |
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM |
12/03/2012 |
K153428 |
ORTHOFIX INC. |
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System |
01/29/2016 |
K171082 |
Orthofix Inc. |
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System |
05/05/2017 |
K180179 |
Orthofix Inc. |
Firebird« Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird« NXG Spinal Fixation System; Phoenix« Minimally Invasive Spinal Fixation System; Phoenix« CDXÖ Minimally Invasive Spinal Fixation System; JANUS« Midline Fixation Screw |
08/24/2018 |
K130932 |
ORTHOFIX, INC. |
FIREBIRD SPINAL FIXATION SYSTEM |
08/07/2013 |
K141186 |
ORTHOFIX, INC. |
FIREBIRD SPINAL FIXATION SYSTEM |
01/02/2015 |
K151488 |
Orthofix, Inc. |
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
07/07/2015 |
K111448 |
ORTHOFIX, INC. |
ICON (TM) MODULAR PEDICLE SCREW SYSTEM |
02/16/2012 |
K160466 |
ORTHOPEDIATRICS CORP. |
Response 5.5 Spine System |
03/23/2016 |
K150600 |
ORTHOPEDIATRICS CORP. |
Response 5.5/6.0 Spine System |
05/22/2015 |
K181390 |
OrthoPediatrics, Corp |
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System |
09/18/2018 |
K162576 |
OSSO SURGICAL |
FORTEZZA Spinal Stabilization System |
11/10/2016 |
K161225 |
Paonan Biotech Co., Ltd. |
Paonan Armstrong Posterior Spinal Fixation System |
08/11/2017 |
K180226 |
Paonan Biotech Co., Ltd. |
TREND II Spinal Fixation System- STEP Series |
07/25/2018 |
K090099 |
PARADIGM SPINE, LLC |
DSS STABILIZATION SYSTEM |
06/19/2009 |
K113625 |
PARADIGM SPINE, LLC |
DSS STABILIZATION SYSTEM |
01/10/2012 |
K090408 |
PARADIGM SPINE, LLC |
MODIFICATION TO: DSS STABILIZATION SYSTEM |
03/20/2009 |
K163011 |
Phamedica, Inc. |
PHA S1 Spinal System |
06/29/2017 |
K110679 |
PHYGEN, LLC |
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM |
08/02/2011 |
K103748 |
PHYGEN, LLC |
LAGUNA PEDICLE SCREW SYSTEM |
03/02/2011 |
K120355 |
PHYGEN, LLC |
LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM |
03/07/2012 |
K113366 |
PHYGEN, LLC |
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM |
01/17/2012 |
K110588 |
PHYGEN, LLC |
LEUCADIA PEDICLE SCREW SYSTEM |
05/25/2011 |
K112931 |
PHYGEN, LLC |
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM |
11/02/2011 |
K141282 |
PINNACLE SPINE GROUP |
PGS 5.5 MM CANNULATED PEDICLE SCREW |
12/02/2014 |
K070551 |
PIONEER SURGICAL TECHNOLOGY |
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM |
03/29/2007 |
K080504 |
PIONEER SURGICAL TECHNOLOGY |
PIONEER LOWTOP SPINAL ROD SYSTEM |
03/20/2008 |
K080518 |
PIONEER SURGICAL TECHNOLOGY |
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM |
03/20/2008 |
K041167 |
PIONEER SURGICAL TECHNOLOGY |
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM |
07/23/2004 |
K070973 |
PIONEER SURGICAL TECHNOLOGY |
QUANTUM SPINAL SYSTEM |
07/03/2007 |
K101790 |
PIONEER SURGICAL TECHNOLOGY |
QUANTUM SPINAL SYSTEM, QUANTUM MIS |
03/07/2011 |
K093692 |
PIONEER SURGICAL TECHNOLOGY |
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES |
08/11/2010 |
K130286 |
PIONEER SURGICAL TECHNOLOGY, INC |
STREAMLINE MIS SPINAL FIXATION SYSTEM |
04/01/2013 |
K140696 |
PIONEER SURGICAL TECHNOLOGY, INC |
STREAMLINE TL SPINAL FIXATION SYSTEM |
04/10/2014 |
K111502 |
PIONEER SURGICAL TECHNOLOGY, INC |
STREAMLINE TL SPINAL SYSTEM |
08/23/2011 |
K131100 |
PIONEER SURGICAL TECHNOLOGY, INC |
STREAMLINE TL SPINAL SYSTEM |
06/27/2013 |
K110692 |
PIONEER SURGICAL TECHNOLOGY, INC. |
STREAMLINE TL SPINAL SYSTEM |
05/12/2011 |
K150856 |
PRECISION SPINE, INC. |
Reform Pedicle Screw System |
07/07/2015 |
K151422 |
Precision Spine, Inc. |
Reform Pedicle Screw System |
08/21/2015 |
K143248 |
PRECISION SPINE, INC. |
Reform Pedicle Screw System |
12/19/2014 |
K173130 |
Precision Spine, Inc. |
Reform« Midline Cortical Screw System |
12/19/2017 |
K150380 |
Premia Spine Ltd. |
ProMIS Fixation System |
07/17/2015 |
K170061 |
Premia Spine Ltd. |
ProMISÖ Fixation System |
02/02/2017 |
K182598 |
Premia Spine Ltd. |
VersaLinkÖ Fixation System |
11/13/2018 |
K180655 |
Presidio Surgical |
Viking Lumbar Polyaxial Screw System |
07/13/2018 |
K112684 |
QUALGENIX |
MONT BLANC PEDICLE SCREW SYSTEMS |
05/01/2012 |
K120091 |
R&D INNOVATION, LLC |
R&D INNOVATION PEDICLE SCREW SYSTEM |
05/18/2012 |
K181495 |
Republic Spine, L.L.C. |
Republic Spine Dark Star Spinal System |
07/25/2018 |
K110046 |
ROYAL OAK MEDICAL DEVICES |
ATHENA PEDICLE SCREW SYSTEM |
12/07/2011 |
K151747 |
SAFE ORTHOPAEDICS |
STERISPINE PS |
10/05/2015 |
K151921 |
SAFE ORTHOPAEDICS |
STERISPINE PS |
10/08/2015 |
K140802 |
SAFE ORTHOPAEDICS |
STERISPINE PS |
06/04/2014 |
K130632 |
SAFE ORTHOPAEDICS |
STERISPINE PS PEDICLE SCREW |
05/03/2013 |
K150092 |
SAFE ORTHOPAEDICS |
STERISPINE PS Pedicle Screw |
02/10/2015 |
K112453 |
SAFE ORTHOPAEDICS |
STERISPINEPS PEDICLE SCREW |
11/15/2011 |
K121299 |
SAFE ORTHOPAEDICS |
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD |
07/30/2012 |
K170528 |
SAFE ORTHOPAEDICS |
SterispineÖ PS |
03/09/2017 |
K043232 |
SEASPINE |
UCR SPINAL SYSTEM |
12/21/2004 |
K160902 |
SEASPINE ORTHOPEDICS CORPORATION |
Mariner Pedicle Screw System |
05/26/2016 |
K180686 |
SeaSpine Orthopedics Corporation |
SeaSpine Daytona Small Stature Spinal System |
05/14/2018 |
K173882 |
SeaSpine Orthopedics Corporation |
SeaSpine Mariner Pedicle Screw System |
02/06/2018 |
K180176 |
SeaSpine Orthopedics Corporation |
SeaSpine NewPort Spinal System |
02/20/2018 |
K163604 |
SeaSpine Orthopedics Corporation |
SeaSpine« Daytona« Small Stature Spinal System |
03/09/2017 |
K161535 |
SEASPINE ORTHOPEDICS CORPORATION |
SeaSpine« NewPortÖ Spinal System |
09/08/2016 |
K061342 |
SEASPINE, INC. |
MALIBU SPINAL SYSTEM |
10/25/2006 |
K072605 |
SEASPINE, INC. |
MALIBU SPINAL SYSTEM |
12/20/2007 |
K051663 |
SEASPINE, INC. |
MALIBU SPINAL SYSTEM |
07/12/2005 |
K122571 |
SEASPINE, INC. |
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM |
12/12/2012 |
K083089 |
SEASPINE, INC. |
NEWPORT SPINAL SYSTEM |
01/13/2009 |
K151849 |
Senecka Spine |
Seneka I Polyscrew Pedicle Fixation System |
09/30/2015 |
K153525 |
Senecka Spine |
Seneka II Polyscrew Pedicle Fixation System |
01/28/2016 |
K170861 |
Shandong Weigao Orthopaedic Device Co., Ltd. |
Premier |
08/04/2017 |
K152781 |
SHANGHAI SANYOU MEDICAL CO, LTD |
Adena-Zina System |
02/12/2016 |
K180754 |
Signature Orthopaedics Pty Ltd. |
C-Zero Pedicle Screw System, Freedom Pedicle Screw System |
12/07/2018 |
K092073 |
SIGNUS MEDICAL |
MONOPOLY PEDICLE SCREW SYSTEM |
08/07/2009 |
K081108 |
SIGNUS MEDICAL LLC. |
MONOPOLY PEDICLE SCREW SYSTEM |
07/14/2008 |
K151704 |
SIGNUS Medizintechnik GmbH |
Diplomat« Spinal System |
04/13/2016 |
K171421 |
Silony Medical GmbH |
VERTICALE« Posterior Spinal Fixation System/VERTICALE« System |
01/10/2018 |
K094002 |
SPARTEK MEDICAL, INC. |
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM |
05/07/2010 |
K103383 |
SPARTEK MEDICAL, INC. |
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM |
02/17/2011 |
K180220 |
Spinal Analytics & Geometrical Implant Co, LLC |
SAGICO OSI Spinal System by Osimplant |
05/21/2018 |
K151770 |
Spinal Balance Inc. |
Libra Pedicle Screw System |
11/20/2015 |
K162750 |
Spinal Balance, Inc. |
Libra Pedicle Screw System |
10/27/2016 |
K030625 |
SPINAL CONCEPTS, INC. |
SPINAL CONCEPTS INC. PATHFINDER |
03/28/2003 |
K030087 |
SPINAL CONCEPTS, INC. |
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM |
07/17/2003 |
K151215 |
Spinal Elements Inc. |
Mercury Spinal System |
06/03/2015 |
K172967 |
Spinal Elements Inc. |
Mercury« Spinal System |
04/10/2018 |
K071914 |
SPINAL ELEMENTS, INC. |
MERCURY SPINAL SYSTEM |
10/12/2007 |
K082353 |
SPINAL ELEMENTS, INC. |
MERCURY SPINAL SYSTEM |
01/22/2009 |
K091587 |
SPINAL ELEMENTS, INC. |
MERCURY SPINAL SYSTEM |
07/01/2009 |
K083230 |
SPINAL ELEMENTS, INC. |
MERCURY SPINAL SYSTEM |
12/03/2008 |
K141372 |
SPINAL ELEMENTS, INC. |
MERCURY SPINAL SYSTEM |
08/22/2014 |
K120467 |
SPINAL ELEMENTS, INC. |
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM |
07/30/2012 |
K170045 |
Spinal Resources, Inc. |
SwedgeÖ Pedicle Screw Fixation System |
06/26/2017 |
K172175 |
Spine Wave, Inc. |
CapSure« PS System |
08/16/2017 |
K182954 |
Spine Wave, Inc. |
SalvoÖ Spine System |
12/12/2018 |
K172101 |
Spineart |
ROMEO« 2 Posterior Osteosynthesis System |
09/26/2017 |
K110906 |
SPINECRAFT LLC |
APEX SPINE SYSTEM |
07/26/2011 |
K132603 |
SPINECRAFT LLC |
APEX SPINE SYSTEM |
11/20/2013 |
K143683 |
SPINECRAFT LLC |
APEX-DL Spine System |
05/22/2015 |
K150417 |
SPINECRAFT LLC |
ASTRA SPINE SYSTEM |
05/19/2015 |
K160980 |
SPINEOLOGY INC |
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System |
05/26/2016 |
K170268 |
Spineology Inc. |
FortressÖ Pedicular Fixation System |
04/14/2017 |
K170266 |
Spineology Inc. |
PalisadeÖ Pedicular Fixation System |
04/14/2017 |
K171438 |
Spineology Inc. |
PalisadeÖ Pedicular Fixation System |
06/02/2017 |
K170251 |
SPINEOLOGY INC. |
ThresholdÖ Pedicular Fixation System |
04/14/2017 |
K161694 |
Spineology Inc. |
ThresholdÖ Pedicular Fixation System |
07/15/2016 |
K170255 |
SPINEOLOGY INC. |
ThresholdÖ V2 Pedicular Fixation System |
04/14/2017 |
K172107 |
Spineology Inc. |
ThresholdÖ V2 Pedicular Fixation System, ThresholdÖ Pedicular Fixation System, FortressÖ Pedicular Fixation System, PalisadeÖ Pedicular Fixation System |
08/21/2017 |
K140010 |
SPINEOLOGY, INC. |
FORTRESS PEDICLE SCREW SYSTEM |
04/23/2014 |
K152148 |
SPINEOLOGY, INC. |
Fortress Pedicular Fixation System |
09/02/2015 |
K153323 |
SPINEOLOGY, INC. |
Palisade Pedicular Fixation System |
02/23/2016 |
K143403 |
Spineology, Inc. |
Threshold Pedicular Fixation System |
12/18/2014 |
K133066 |
SPINESELECT, LLC |
SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM |
01/13/2014 |
K112607 |
SPINEVISION, S.A. |
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... |
06/07/2012 |
K150185 |
SPINEWAY |
Mont Blanc Spinal System |
05/12/2015 |
K161387 |
SPINEWAY S.A. |
Mont Blanc and Mont Blanc MIS Spinal Systems |
08/04/2016 |
K121342 |
STRYKER CORP |
XIA 4.5 SPINAL SYSTEM |
06/22/2012 |
K073151 |
STRYKER CORP. |
MANTIS SPINAL SYSTEM |
12/06/2007 |
K120434 |
STRYKER CORP. |
POWER ADAPTOR INSTRUMENT ACCESSORY |
03/08/2012 |
K070368 |
STRYKER CORP. |
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM |
05/04/2007 |
K142381 |
STRYKER CORP. |
Xia 3 Spinal System |
10/21/2014 |
K111478 |
STRYKER CORPORATION |
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) |
08/04/2011 |
K103292 |
STRYKER CORPORATION |
TRIO TRAUMA SPINAL SYSTEM |
03/04/2011 |
K152632 |
STRYKER CORPORATION |
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory |
12/02/2015 |
K170496 |
Stryker Corporation |
Xia« 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory |
05/16/2017 |
K172724 |
Stryker Corporation |
XIA« 4.5 Spinal System, Power Adaptor Instrument Accessory |
10/10/2017 |
K070631 |
STRYKER SPINE |
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM |
07/13/2007 |
K122845 |
STRYKER SPINE |
ES2 SPINAL SYSTEM MODEL 48280XXXX |
12/07/2012 |
K133188 |
STRYKER SPINE |
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL |
12/17/2013 |
K092631 |
STRYKER SPINE |
MANTIS REDUX SPINAL SYSTEM |
09/25/2009 |
K102235 |
STRYKER SPINE |
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM |
08/24/2010 |
K060748 |
STRYKER SPINE |
MODIFICATION TO XIA 4.5 SPINAL SYSTEM |
04/13/2006 |
K100737 |
STRYKER SPINE |
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM |
04/12/2010 |
K101144 |
STRYKER SPINE |
MODIFICATION TO:RADIUS SPINAL SYSTEM |
07/08/2010 |
K062270 |
STRYKER SPINE |
RADIUS SPINAL SYSTEM |
11/22/2006 |
K082608 |
STRYKER SPINE |
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 |
10/07/2008 |
K071373 |
STRYKER SPINE |
STRYKER SPINE XIA III SPINAL SYSTEM |
08/27/2007 |
K113666 |
STRYKER SPINE |
XIA 3 SPINAL SYSTEM |
08/28/2012 |
K083393 |
STRYKER SPINE |
XIA 3 SPINAL SYSTEM |
04/01/2009 |
K091291 |
STRYKER SPINE |
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD |
06/24/2009 |
K092605 |
STRYKER SPINE |
XIA 4.5 SPINAL SYSTEM |
12/03/2009 |
K080928 |
STRYKER SPINE |
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS |
04/30/2008 |
K060361 |
STRYKER SPINE |
XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM |
03/06/2006 |
K063428 |
STRYKER SPINE |
XIA STAINLESS STEEL SPINAL SYSTEM |
12/11/2006 |
K060979 |
STRYKER SPINE |
XIA TITANIUM AND 4.5 SPINAL SYSTEMS |
05/19/2006 |
K061854 |
STRYKER SPINE |
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM |
07/27/2006 |
K163363 |
SurgTech Inc. |
SurgTech Thoracolumbosacral (TLS) Posterior Fixation System |
04/05/2017 |
K101971 |
SYNTEC SCIENTIFIC CORP. |
SYNTEC OS SPINAL FIXATION SYSTEM |
03/25/2011 |
K090605 |
SYNTHES (USA) |
CLAMPFIX |
11/06/2009 |
K093668 |
SYNTHES (USA) |
SYNTHES MATRIX MIS RODS |
03/09/2010 |
K092929 |
SYNTHES (USA) |
SYNTHES MATRIX SYSTEM |
12/29/2009 |
K100634 |
SYNTHES (USA) |
SYNTHES MATRIX SYSTEM |
07/01/2010 |
K082914 |
SYNTHES SPINE |
CLAMPFIX |
12/11/2008 |
K100952 |
SYNTHES SPINE |
MODIFICATION TO SYNTHES MATRIX SYSTEM |
08/05/2010 |
K103287 |
SYNTHES SPINE |
SYNTHES 6.0 COCR AND CPT TI-3 RODS |
01/05/2011 |
K120838 |
SYNTHES SPINE |
SYNTHES MATRIX SYSTEM |
07/31/2012 |
K120928 |
SYNTHES SPINE |
SYNTHES MATRIX SYSTEM |
05/18/2012 |
K113044 |
SYNTHES SPINE |
SYNTHES MIRS |
12/21/2011 |
K111358 |
SYNTHES SPINE |
SYNTHES USS |
11/18/2011 |
K120571 |
SYNTHES SPINE |
SYNTHES USS CONNECTOR |
05/14/2012 |
K082572 |
SYNTHES SPINE |
USS ILIOSACRAL, USS POLYAXIAL |
11/24/2008 |
K052151 |
SYNTHES SPINE CO.LP |
SYNTHES PANGEA MONOAXIAL SYSTEM |
12/07/2005 |
K170654 |
Synthes USA Products LLC |
USS System |
03/29/2017 |
K120074 |
THE SKELETAL DESIGN PARTNERSHIP LTD. |
FOUNDATION SPINAL SYSTEM |
03/14/2012 |
K070962 |
THEKEN SPINE LLC |
CORAL PEDICLE SCREW SYSTEM |
08/22/2007 |
K081414 |
THEKEN SPINE LLC |
MODIFICATION TO CORAL SPINAL SYSTEM |
06/17/2008 |
K100970 |
THEKEN SPINE LLC |
STAINLESS STEEL SPINAL SYSTEM |
08/12/2010 |
K091266 |
THEKEN SPINE LLC |
THEKEN CORAL SPINAL SYSTEM |
06/10/2009 |
K120047 |
THEKEN SPINE, LLC |
CORAL SPINAL SYSTEM |
02/03/2012 |
K120829 |
THEKEN SPINE, LLC |
STAINLESS STEEL SPINAL SYSTEM |
05/30/2012 |
K070385 |
TI-TAMED (PTY) LTD |
TI-TAMED SPINAL SYSTEM |
07/31/2009 |
K172267 |
Tianjin Zhengtian Medical Instrument Co.,Ltd. |
IRENE Thoracolumbar Fixation System |
03/06/2018 |
K122229 |
TORREY SPINE |
VICEROY SPINAL SYSTEM |
11/20/2012 |
K173524 |
U&I Corporation |
ANAX 5.5Ö Spinal System |
12/13/2017 |
K181824 |
U&i Corporation |
CBT Screw Fixation System |
12/13/2018 |
K120891 |
ULRICH GMBH & CO. KG |
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM |
10/01/2012 |
K052385 |
ULRICH GMBH & CO. KG |
TANGORS POLYAXIAL SYSTEM |
12/27/2005 |
K123717 |
ULRICH GMBH & CO. KG |
UCENTUM |
03/04/2013 |
K180324 |
Valorus Spine |
Patriot Spinal Fixation System |
04/06/2018 |
K071376 |
VERTEBRON, INC. |
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM |
06/13/2007 |
K073245 |
VERTIFLEX, INC. |
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM |
02/15/2008 |
K172548 |
Wiltrom Corporation Limited |
Wiltrom Spinal Fixation System |
01/12/2018 |
K180153 |
X-spine Systems, Inc. |
X-spine Cortical Bone Screw System |
03/15/2018 |
K170611 |
Xenco Medical, LLC |
SETx Pedicle Screw System |
05/25/2017 |
K160986 |
XENCO MEDICAL, LLC |
Xenco Medical Pedicle Screw System |
05/04/2016 |
K151733 |
Xenco Medical, LLC |
Xenco Medical Pedicle Screw System |
09/04/2015 |
K143200 |
Z-Medical GmbH & Co. KG |
MIS Z-Pedicle Screw System |
02/03/2015 |
K171907 |
Zimmer Biomet Spine, Inc. |
Vitality« Spinal Fixation System |
07/14/2017 |
K172275 |
Zimmer Biomet Spine, Inc. |
Vitality« Spinal Fixation System, Vitality«+ Power Instrument System |
09/27/2017 |
K123552 |
ZIMMER SPINE |
INSTINCT JAVA SYSTEM |
04/19/2013 |
K113270 |
ZIMMER SPINE |
INSTINCT JAVA SYSTEM |
12/16/2011 |
K111301 |
ZIMMER SPINE |
INSTINCT JAVA SYSTEM |
08/26/2011 |
K100845 |
ZIMMER SPINE, INC |
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES |
09/21/2010 |
K133291 |
ZIMMER SPINE, INC |
ST360 DEGREES SPINAL FIXATION SYSTEM |
12/17/2013 |
K142752 |
ZIMMER SPINE, INC. |
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360? Spinal Fixatoin System, Title 2 Polyaxial Spinal System |
06/18/2015 |
K121671 |
ZIMMER SPINE, INC. |
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM |
07/18/2012 |
K132884 |
ZIMMER SPINE, INC. |
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM |
11/25/2013 |
K131980 |
ZIMMER SPINE, INC. |
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM |
09/04/2013 |
K042702 |
ZIMMER SPINE, INC. |
SILHOUETTE SPINAL FIXATION SYSTEM |
11/23/2004 |
K072183 |
ZIMMER SPINE, INC. |
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 |
09/05/2007 |
K133086 |
ZIMMER SPINE, INC. |
TITLE 2 POLYAXIAL SPINAL SYSTEM |
11/27/2013 |
K150896 |
ZIMMER SPINE, INC. |
Vitality Spinal Fixation System |
08/31/2015 |