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
K123939 AESCULAP IMPLANT SYSTEMS, INC. S4 SPINAL SYSTEM 03/12/2013
K123352 AESCULAP IMPLANT SYSTEMS, INC. S4 SPINAL SYSTEM 12/12/2012
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
K051024 DEPUY SPINE, INC. EXPEDIUM SPINE SYSTEM 07/06/2005
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
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
K063156 DEPUY SPINE, INC. MODIFICATION TO EXPEDIUM SPINE SYSTEM 11/22/2006
K090799 DEPUY SPINE, INC. MODIFICATION TO EXPEDIUM SPINE SYSTEM 04/22/2009
K080313 DEPUY SPINE, INC. MODIFICATION TO EXPEDIUM SPINE SYSTEM 05/08/2008
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
K073510 ENDIUS, INC. ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM 02/11/2008
K060990 ENDIUS, INC. ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM 04/26/2006
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
K171559 Innovative Surgical Designs, Inc. True Spinal Fixation System 07/24/2017
K170710 Innovative Surgical Designs, Inc. True Spinal Fixation System 07/14/2017
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
K141398 MEDICREA INTERNATIONAL S.A. PASS LP SPINAL SYSTEM 01/09/2015
K161627 MEDICREA INTERNATIONAL S.A. PASS LP Spinal System 07/29/2016
K153413 MEDICREA INTERNATIONAL S.A. PASS LP Spinal System 04/22/2016
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
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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
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K032560 MEDTRONIC SOFAMOR DANEK ARROWHEAD SPINAL SYSTEM 03/09/2004
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K090390 MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM 05/15/2009
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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
K042962 MEDTRONIC SOFAMOR DANEK MODIFICATION TO CD HORIZON SPINAL SYSTEM 12/14/2004
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K081080 MEDTRONIC SOFAMOR DANEK TSRH SPINAL SYSTEM 11/21/2008
K110676 MEDTRONIC SOFAMOR DANEK TSRH SPINAL SYSTEM 05/23/2011
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K103049 MEDTRONIC SOFAMOR DANEK TSRH SPINAL SYSTEM 12/23/2010
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K101772 MEDTRONIC SOFAMOR DANEK TSRH(R) SPINAL SYSTEM 09/30/2010
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K132111 MEDTRONIC SOFAMOR DANEK USA CD HORIZON SPINAL SYSTEM 08/06/2013
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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


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