FDA 510(k) Applications for Medical Device Product Code "NKB"
(Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease)

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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact