FDA 510(k) Applications for Medical Device Product Code "ODP"
(Intervertebral Fusion Device With Bone Graft, Cervical)

FDA 510(k) Number Applicant Device Name Decision Date
K121741 4-WEB, INC. 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) 10/18/2012
K221266 4WEB Medical, Inc. Cervical Spine Truss System (CSTS) Interbody Fusion Device 01/05/2023
K173159 4Web, Inc. Cervical Spinal Truss System (CSTS) Interbody Fusion Device 01/08/2018
K181471 Absolute Advantage Medical, LLC ACCUFUSE Cervical System 08/29/2018
K121569 ACCEL SPINE MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM 07/27/2012
K143450 ACKERMANN INSTRUMENTE GMBH Ackermann Intervertebral Body Fusion Device 09/16/2015
K083425 ADAPTIVE SPECIALTY, LLC FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE 03/20/2009
K191812 Additive Device, Inc. (ADI) d/b/a restor3d ADI Cervical Interbody Fusion Device 10/24/2019
K193359 Additive Implants, Inc SureMAX Family of Cervical Spacers 01/03/2020
K182477 Additive Implants, LLC Cervical Spacer 01/28/2019
K190291 Addivation Medical, LLC Addivation Medical Cervical Interbody System 07/30/2019
K123909 AESCULAP IMPLANT SYSTEM, INC. AESCULAP CESPACE XP 04/15/2013
K083311 AESCULAP IMPLANT SYSTEMS, INC. AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM 03/04/2009
K112361 ALLIANCE PARTNERS, LLC ALAMO C 11/30/2011
K133321 ALLIANCE PARTNERS, LLC ALAMO C 01/09/2014
K173128 Alliance Partners, LLC Alamo« C 03/22/2018
K222973 Alphatec Spine Inc. IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interb 11/17/2022
K181435 Alphatec Spine, Inc. ATEC Cervical Spacer System 08/21/2018
K081730 ALPHATEC SPINE, INC. NOVEL CERVICAL SPINAL SPACER SYSTEM 09/19/2008
K172253 Altus Partners, LLC Altus Spine Cervical Interbody Fusion System 11/21/2017
K142264 Amedica Corp. Valeo C Spacer System, Valeo II C IBF Device 12/08/2014
K173453 Amedica Corp. Valeo« C+CSC with Lumen Interbody Fusion Device 03/05/2018
K120143 APOLLO SPINE ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL 02/16/2012
K173324 Astura Medical ALTA Anterior Cervical Interbody Spacer 02/27/2018
K160154 Astura Medical ALTA Anterior Cervical Interbody Spacer 05/13/2016
K081880 ATLAS SPINE INC. ATLAS SPINE SPACER 10/02/2008
K180675 Atlas Spine, Inc. Atlas Spine Expandable Cervical Interbody System 06/13/2018
K202302 Atlas Spine, Inc. Atlas Spine Rebar (Ti) Spacer System 10/30/2020
K210521 Aurora Spine, Inc. DEXA-C Cervical Interbody System 08/02/2021
K181140 Axis Orthopaedics Axis Chena Cervical PEEK Spacer System 11/16/2018
K191537 Back 2 Basics Direct, LLC eCarbon IBDs 09/26/2019
K200458 BeSpoke Technologies Tailored-C Cervical Interbody Fusion System 12/28/2020
K132483 BK MEDITECH CO., LTD. INNESIS PEEK CERVICAL CAGE 04/02/2014
K203520 Blustone Synergy, LLC Blustone Synergy Interbody Fusion System 04/07/2021
K122518 BM KOREA CO., LTD. SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE 02/15/2013
K111820 BM KOREA CO., LTD. SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE 03/14/2012
K102449 BRIGHT SPINE, INC BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM 02/11/2011
K133529 CAMBER SPINE CAMBER SPINE COVERIS CERVICAL CAGE 03/20/2014
K170550 Camber Spine Technologies Coveris Cervical Cage System 07/13/2017
K172446 Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody 11/07/2017
K142586 CAPTIVA SPINE Captiva Spine FuselOX Cervical IBF System 05/28/2015
K110585 CAPTIVA SPINE, INC CAPTIVA SPINE FUSELOX CERVICAL CAGE 03/25/2011
K181229 Captiva Spine, Inc. TirboLOX-C Cervical IBFD 09/19/2018
K222874 CarboFix Orthpedics Ltd. CarboClear Cervical Cage System, CarboClear Cervical VBR System 07/26/2023
K100698 CARDINAL SPINE, LLC STCC 03/14/2011
K091531 CHOICE SPINE, LLP CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER 11/02/2009
K191621 ChoiceSpine, LLC ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan 08/15/2019
K201643 ChoiceSpine, LLC ChoiceSpine Tiger Shark Cervical Spacer System 12/22/2020
K183397 ChoiceSpine, LP ChoiceSpine Stealth Cervical Spacer System 03/06/2019
K130853 CLARIANCE IDYS(TM) C 11/13/2013
K173148 coLigne, AG ACIF 12/01/2017
K150847 CORELINK LLC Foundation Interbody Devices 08/13/2015
K230329 Corelink, LLC F3D Interbody System 06/06/2023
K162496 CoreLink, LLC Foundation 3D Interbody 05/04/2017
K162682 CTL Medical Corporation MATISSE Anterior Cervical Interbody Fusion Cage System 06/01/2017
K172212 CTL Medical Corporation MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKÖ 01/09/2018
K172788 CTL Medical Corporation MONETÖ Anterior Cervical Interbody Fusion Cage System 06/25/2018
K220513 CTL Medical Corporation NITRO Interbody Fusion Cage System Family 04/25/2023
K213030 Curiteva, Inc. Curiteva Porous PEEK Cervical Interbody Fusion System 02/13/2023
K181261 Curiteva, LLC Curiteva Cervical Interbody Fusion System 07/09/2018
K092904 CUSTOM SPINE, INC. PATHWAY IVB/VBR 12/22/2009
K180674 Cutting Edge Spine, LLC EVOL« ha-C Cervical Interbody Fusion System 06/25/2018
K151496 Degen Medical Latitude-C Cervical Interbody Spacer System 12/15/2015
K222276 DePuy Spine CONDUIT Cages; FIBERGRAFT BG Putty 10/15/2022
K162220 DIO MEDICAL CO., LTD DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage 11/21/2016
K122872 DIO MEDICAL CO., LTD. INTERVERTEBRAL BODY FUSION DEVICE 02/28/2013
K122444 EISERTECH, LLC CERVICAL CAGE 08/30/2012
K110915 EISERTECH, LLC CERVICAL CAGE 07/22/2011
K212701 Eminent Spine Eminent Spine 3D Cervical Interbody Fusion System 02/06/2023
K160324 EVOLUTION SPINE, LLC Cervical Interbody Fusion System 05/05/2016
K150130 EXACTECH, INC. Ascendant TM Cervical Spacer System 05/28/2015
K141129 EXACTECH, INC. EXACTECH CERVICAL SPACER SYSTEM 08/15/2014
K103655 EXACTECH, INC. OCTANE-C INTERBODY FUSION DEVICE SYSTEM 06/30/2011
K223231 FloSpine Ti-Largo Cervical Interbody System 02/24/2023
K210890 G Surgical LLC GPS Cervical Spacers 04/23/2021
K142456 G SURGICAL, LLC GPS Spacers 04/10/2015
K213980 GBS Commonwealth Co., Ltd. Peridot Spinal Interbody System 03/15/2022
K213755 GBS Commonwealth Co., Ltd. Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system 02/17/2023
K230708 GBS Commonwealth Co., Ltd. Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) 05/22/2023
K202872 GBS Commonwealth Co., Ltd. Prase PEEK Anterior Cervical Interbody Spacer 02/04/2021
K150812 Genesys Spine Genesys Spine Apache Cervical Interbody Fusion System 09/03/2015
K130317 GENESYS SPINE GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM 12/11/2013
K142218 GLOBUS MEDICAL INC. Coalition AGX Plate and Coalition AGX Spacer 03/31/2015
K173115 Globus Medical Inc. COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS 12/20/2017
K191243 Globus Medical Inc. HEDRON Cervical Spacers 09/17/2019
K222270 Globus Medical Inc. HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments 10/21/2022
K173722 Globus Medical Inc. PATRIOT COLONIAL Spacer, SUSTAIN Spacer 05/23/2018
K180909 Globus Medical Inc. REVEL Spacers 12/18/2018
K072991 GLOBUS MEDICAL, INC. PATRIOT SPACERS: COLONIAL ACDF 01/18/2008
K153517 GS Medical Co., Ltd. AnyPlus« Cervical PEEK Cage System 06/24/2016
K200592 GS Medical Co., Ltd. GS Medical AnyPlus PEEK Cage System 08/10/2020
K222004 HAPPE Spine INTEGRATE -C Interbody Fusion System 04/28/2023
K180364 HD LifeSciences LLC HD LifeSciences Cervical IBFD System 06/27/2018
K222988 HT Medical d.b.a. Xenix Medical neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical 09/01/2023
K170318 HT Medical, LLC NeoFuse Ti3D PLIF/TLIF/Cervical Interbody 07/12/2017
K192897 icotec ag icotec Cervical Cage 03/20/2020
K172480 icotec ag icotec Interbody Cage System 05/17/2018
K230026 Implanet, S.A. SQUALE 03/28/2023
K132991 INNOVASIS, INC. C-BOX PEEK CERVICAL IBF 02/12/2014
K181115 Innovasis, Inc. CxHA PEEK Cervical IBF System 07/16/2018
K220875 Innovasis, Inc. HAcancellous PEEK-C Porous HA PEEK Cervical IBF System 08/26/2022
K223510 Innovasis, Inc. Matrix HA Fusion Porous Cervical IBF System 12/12/2022
K132718 INTEGRITY SPINE INTEGRITY SPINE CORE SYSTEM 11/18/2013
K223043 Integrity Spine The Integrity Spine Core System 03/20/2023
K081614 INTERBODY INNOVATIONS, LLP ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES 09/05/2008
K111484 INTUITIVE SPINE, LLC DISCOVERY 09/12/2011
K212266 Jeil Medical Corporation FIX-C PEEK Anterior Cervical Interbody System 12/21/2021
K201793 JMT Co., Ltd EDEN Peek Cage 09/13/2021
K212038 K&J Consulting Corporation K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage 08/27/2021
K160125 K2M Cascadia Interbody System 04/22/2016
K101302 K2M, INC. ALEUTIAN IBF SYSTEM 07/22/2010
K103169 K2M, INC. ALEUTTIAN 03/07/2011
K123388 K7 LLC K7C SPACER 01/04/2013
K213115 Kahtnu Surgical, Inc CHENA-C Spacer System 12/06/2021
K133815 KALITEC DIRECT, LLC INTESS CERVICAL CAGE SYSTEM 04/16/2014
K180401 Kalitec Direct, LLC TiWAVE-CÖ Porous Titanium Cervical Cage 06/14/2018
K212450 Keos Keos Anterior Cervical Interbody Fusion Device System 06/06/2022
K120840 L&K BIOMED CO., LTD LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM 05/24/2012
K143360 L&K BIOMED Co., Ltd LnK Cervical Interbody Fusion Cage System 04/03/2015
K151677 L&K BIOMED Co.,Ltd. LnK Cervical Interbody Fusion Cage System 07/15/2015
K103660 LANX, INC. LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM 02/28/2011
K091088 LDR SPINE USA LDR SPINE CERVICAL INTERBODY FUSION SYSTEM 07/14/2009
K113559 LDR SPINE USA INC. LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS 12/29/2011
K192208 Legend Spine Technologies CORNICE Cervical Spacer System 10/09/2019
K093093 LIFE SPINE SMALL PLATEAU SPACER SYSTEM 10/13/2010
K161127 LIFE SPINE INC. The Small PLATEAU (PLATEAU-C) Spacer System 12/22/2016
K111835 LIFE SPINE, INC PLATEAU SPACER SYSTEM 07/19/2011
K211501 lntelivation, LLC Advantage-C PEEK Cervical lnterbody Fusion Device 08/24/2021
K200549 Lucero Medical, LLC Lucero Medical Cervical Cage System 12/16/2020
K123206 MAXIM SURGICAL MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM 02/07/2013
K112862 MEDACTA INTERNATIONAL MECTA-C 12/19/2011
K142744 Medacta International Mecta-C TiPEEK 05/07/2015
K172587 Medacta International SA Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers 09/18/2017
K100484 MEDICREA IMPIX MANTA CERVICAL INTERBODY DEVICE 03/16/2010
K122850 MEDITECH ADVISORS, LLC TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES 03/28/2013
K150788 MEDITECH SPINE, LLC Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices 10/14/2015
K142345 MEDITECH SPINE, LLC Talos-C(HA) Cervical Intervertebral Body Fusion Devices 02/22/2015
K201506 Meditech Spine, LLC Talos«-C Cervical Intervertebral Body Fusion System, Talos«-C (HA) Cervical Intervertebral Body Fusion System 09/11/2020
K120517 MEDOS INTERNATIONAL SARL DEPUY PULSE CERVICAL CAGE SYSTEM 04/26/2012
K112444 MEDTRONIC SOFAMOR DANCK USA, INC. ANATOMIC PEEK CERVICAL FUSION SYSTEM 11/15/2011
K153373 Medtronic Sofamor Danek CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device 01/19/2016
K100214 MEDTRONIC SOFAMOR DANEK CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE 06/25/2010
K111264 MEDTRONIC SOFAMOR DANEK USA CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM 10/12/2011
K142450 MEDTRONIC SOFAMOR DANEK USA, INC DIVERGENCE Anterior Cervical Fusion System 10/01/2014
K153438 MEDTRONIC SOFAMOR DANEK USA, INC PERIMETER C (Titanium) Spinal System 03/02/2016
K130177 MEDTRONIC SOFAMOR DANEK USA, INC. ANATOMIC PEEK CERVICAL FUSION SYSTEM 09/23/2013
K133653 MEDTRONIC SOFAMOR DANEK USA, INC. ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM 04/28/2014
K100967 MEDTRONIC SOFAMOR DANEK USA, INC. PERIMETER C SPINAL SYSTEM 08/05/2011
K132584 MEDTRONIC SOFAMOR DANEK USA, INC. PERIMETER C SPINAL SYSTEM 12/04/2013
K160528 MEDTRONIC SOFAMOR DANEK, USA, INC. ANATOMIC PEEK PTC Cervical Fusion System 03/28/2016
K212792 Medynus Inc. Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage 09/23/2021
K121320 MEDYSSEY CO., LTD. C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE 08/10/2012
K132732 MEDYSSEY USA, INC. MEDYSSEY ANTERIOR CERVICAL FUSION CAGE 07/18/2014
K161649 Met 1 Technologies, LLC Virtu C Spinal Implant System 11/09/2016
K222806 Met One Technologies, LLC Kodiak C Spinal Implant System 12/22/2022
K200685 MiRus, LLC RIGEL 3DR Anterior Cervical Interbody Fusion System 06/11/2020
K190618 MiRus, LLC RIGEL PEEK Anterior Cervical Interbody Fusion System 06/06/2019
K101363 MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS VU CPOD INTERVERTEBRAL BODU FUSION DEVICE 12/16/2010
K230936 Nanovis LLC Anatomic PEEKÖ Cervical Fusion System with Nanotechnology 06/02/2023
K191822 Nanovis LLC Nano FortiCore, FortiCore 10/11/2019
K140280 NANOVIS, LLC FORTICORE 09/05/2014
K110442 NANOVIS, LLC NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM 11/09/2011
K201769 NeuroStructures, Inc. Cavetto [MAX] Cervical Cage System 09/03/2020
K181590 NeuroStructures, Inc. Neurostructures Cavetto« [MAX] Cervical Cage System 11/08/2018
K172320 NeuroStructures, Inc. Neurostructures Cavetto« Cervical Cage System 02/26/2018
K161608 NEXT ORTHOSURGICAL InterForm Cervical Interbody Cage System 09/30/2016
K120345 NEXXT SPINE LLC HONOUR SPACER SYSTEM 06/13/2012
K171140 Nexxt Spine LLC Matrixx System 08/22/2017
K200429 NGMedical GmbH BEE Cages 01/29/2021
K203444 NGMedical GmbH BEE HA Cage 03/18/2021
K140003 NUVASIVE, INC. COROENT SMALL INTERBODY SYSTEM 04/03/2014
K081611 NUVASIVE, INC. NUVASIVE COROENT SYSTEM 10/02/2008
K223731 Nuvasive, Inc. NuVasive Modulus-C Interbody System 01/12/2023
K140921 NUVASIVE, INCORPORATED COROENT SMALL INTERBODY SYSTEM 07/28/2014
K142050 NUVASIVE, INCORPORATED NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM 10/29/2014
K150362 NuVasive, Incorporated NuVasive CoRoent Small Interbody System 06/11/2015
K163491 NuVasive, Incorporated NuVasive CoRoent Small Interbody System 03/24/2017
K231735 NuVasive, Incorporated NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System 07/11/2023
K162138 NUVASIVE, INCORPORATED NuVasive CoRoent Small Ti-C System 10/26/2016
K172676 NuVasive, Incorporated NuVasive« Modulus-C Interbody System 12/14/2017
K173030 NuVasive, Incorporated Vertera Spine Cohere Cervical Interbody Fusion Device 11/21/2017
K222015 Nvision Biomedical Technologies, Inc Integral Titanium Cervical Interbody 07/05/2023
K190380 Nvision Biomedical Technologies, Inc. nvc 03/21/2019
K170074 Nvision Biomedical Technologies, LLC nvc 01/24/2017
K142328 NVISION BIOMEDICAL TECHNOLOGIES, LLC nvc 12/23/2014
K122085 OMNI SURGICAL, LP DBA SPINE360 STINGRAY CERVICAL CAGE 10/17/2012
K163265 Orbbo Surgical, LLC Kepler II 04/07/2017
K122588 ORTHO DEVELOPMENT CORP. VUSION CS PLUS 06/12/2013
K121649 ORTHOFIX CONSTRUX MINI PEEK TI SPACER SYSTEM 11/29/2012
K101812 ORTHOFIX INC. CONSTRUX MINI PEEK SPACER SYSTEM 09/27/2010
K202949 Orthofix Inc. CONSTRUX Mini PEEK Spacer System 10/29/2020
K150619 Orthofix Inc. CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System 09/11/2015
K211704 Orthofix Inc. CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervica 08/31/2021
K202666 Orthofix Inc. CONSTRUX Mini PTC Spacer System 10/14/2020
K200052 Orthofix Inc. CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System 04/09/2020
K203342 Orthofix Inc. CONSTRUX Mini Ti Spacer System 03/18/2021
K172437 Orthofix Inc. CONSTRUX« Mini PTC Spacer System, FORZA« PTC Spacer System, PILLAR« SA PTC Spacer System 11/02/2017
K142152 ORTHOFIX, INC. CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM 01/08/2015
K101171 ORTHOVITA, INC. ORTHOVITA PEEK SPACER 01/25/2011
K170844 Osseus Fusion Systems, LLC Gemini-C Hybrid Cervical Interbody System 07/03/2017
K143572 Osteomed Implantes, LTDA Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK 06/10/2015
K220261 Paonan Biotech Co., Ltd. NEST-C Interbody System 04/24/2023
K213493 Paradigm Spine Fortilink with TiPlus Technology 01/27/2022
K140066 PINNACLE SPINE GROUP, LLC INFILL CERVICAL 05/05/2014
K133623 PIONEER SURGICAL TECHNOLOGY, INC C-PLUS 02/10/2014
K142041 POROSTEON, INC. POROSTEON PHUSION METAL CERVICAL CAGE 12/19/2014
K172568 PRECIFIT MEDICAL LTD Cervage 05/04/2018
K161809 Precision Spine, Inc. ShurFit CpTi-HA ACIF Interbody Fusion System 12/06/2016
K161642 PROVIDENCE MEDICAL TECHNOLOGY, INC CAVUXÖ Cervical Cage 10/07/2016
K122801 PROVIDENCE MEDICAL TECHNOLOGY, INC. PROVIDENCE CERVICAL CAGE 05/24/2013
K112801 QUALGENIX AYERS ROCK CERVICAL CAGE 05/01/2012
K120396 Reliance Medical Systems, LLC RELIANCE CERVICAL IBF SYSTEM 05/08/2012
K173102 Reliance Medical Systems, LLC Reliance Cervical IBF System 12/29/2017
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 06/09/2015
K172489 Reliance Medical Systems, LLC Reliance Cervical IBF System 09/07/2017
K202266 Reliance Medical Systems, LLC Reliance Cervical IBF System 03/29/2022
K131429 Reliance Medical Systems, LLC RELIANCE CERVICAL IBF SYSTEM 09/23/2013
K190889 Republic Spine, L.L.C. Republic Spine Restore Cervical Interbody Fusion System 06/19/2019
K150455 RHAUSLER, INC. RT2 Trabeculite Titanium Cervical Cage System 11/19/2015
K092540 RSB SPINE LLC. C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER 01/27/2010
K163673 RTI Surgical, Inc. FortilinkÖ-C with TETRAfuseÖ 3D Technology 05/23/2017
K150521 RTI SURGICAL, INC. dba RTI BIOLOGICS Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System 05/15/2015
K192316 Sapphire Medical Group Matrix HA PEEK Cervical Implant System 10/17/2019
K172674 Sapphire Medical Group Sapphire Cervical Implant System 11/02/2017
K220296 SeaSpine Orthopedics Corporation Manta Ray TDF Spacer 02/03/2023
K171046 SeaSpine Orthopedics Corporation SeaSpine Cambria System 07/07/2017
K172926 SeaSpine Orthopedics Corporation SeaSpine Vu cPOD, Zuma-C, Complete Cervical 12/21/2017
K183083 SeaSpine Orthopedics Corporation Shoreline Cervical Interbody RT System 02/14/2019
K082309 SEASPINE, INC. CAMBRIA 04/09/2009
K163422 SHANGHAI SANYOU MEDICAL CO, LTD Shanghai Sanyou PEEK Cage System 09/18/2017
K082848 SIGNUS MEDIZINTECHNIK GMBH NUBIC AND RABEA DEVICES 07/24/2009
K182608 Silony Medical GmbH Oyster ACIF Cage 06/13/2019
K162587 SILONY MEDICAL GMBH ROCCIA« ACIF 01/26/2017
K192044 Solco Biomedical Co., Ltd. 4CIS Marlin PEEK ACIF Cage 12/19/2019
K162402 SOLCO BIOMEDICAL CO., LTD. 4CIS« Marlin ACIF Cage System 02/16/2017
K230607 Southern Medical (Pty) Ltd SPICCA Cervical Fusion Cages 08/14/2023
K130948 SOUTHERN SPINE, LLC C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM 08/14/2013
K083167 SPINAL DEVICES, LLC PHENIX CERVICAL INTERBODY DEVICE 01/13/2009
K073351 SPINAL ELEMENTS, INC. CRYSTAL 01/24/2008
K222833 Spinal Elements, Inc. VentanaÖ C Spinal System 05/19/2023
K083118 SPINAL USA SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE 05/27/2009
K073320 SPINE SMITH PARTNERS L.P. CIMPLICITY SPINAL SYSTEM 02/07/2008
K172065 SPINEART SCARLET AC-T 09/29/2017
K190322 Spineart SCARLET« AC-T Secured Anterior Cervical Cage 03/04/2019
K091873 SPINEART TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S 09/18/2009
K122366 SPINEART TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE 10/04/2012
K200312 Spineart Tryptik Ti 04/06/2020
K230583 Spineart SA Tryptik Ti 03/22/2023
K090887 SPINECRAFT ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES 10/30/2009
K211935 SpineCraft, LLC ORIO-Ti Intervertebral Body Fusion Cage System 09/30/2021
K141337 SPINEFRONTIER, INC. ARENA-C 09/08/2014
K141333 SPINEFRONTIER, INC. ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE 11/25/2014
K113518 SPINEFRONTIER, INC. ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM 02/16/2012
K142026 SPINEFRONTIER, INC. SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE 10/20/2014
K110733 SPINENET, LLC DAYTONA ANTERIOR CERVICAL CAGE 08/25/2011
K162694 Spineway Ayers Rock Cervical interbody fusion system 01/12/2017
K142251 Stryker Corporation AVS AS PEEK Spacer 11/19/2014
K152532 STRYKER SPINE AERO -C Cervical Cage System 12/18/2015
K161407 Stryker Spine Ascential IBD PEEKc Spacer 07/15/2016
K120486 STRYKER SPINE AVS AS PEEK SPACER 08/20/2012
K171496 STRYKER SPINE Tritanium C Anterior Cervical Cage 09/06/2017
K221490 Stryker Spine Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement Syste 02/14/2023
K163494 Summit Spine Summit Spine Channel Cervical Interbody Fusion System 06/20/2017
K120275 SYNTHES (USA) LLC SYNTHES ACIS/VERTEBRAL SPACER CR 05/25/2012
K162003 The Institute of Musculoskeletal Science & Education IMSE Cervical Cage 12/21/2016
K160222 THE ORTHOPAEDIC IMPLANT COMPANY OIC Cervical PEEK Spacer 12/07/2016
K111675 THEKEN SPINE LLC VU C*POD INTERVERTEBRAL BODY FUSION DEVICE 08/02/2011
K192018 Titan Spine, Inc Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody 08/16/2019
K183557 Titan Spine, Inc Endoskeleton« TA Interbody Fusion Device, Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TO Interbody Fusion Device, Endoskeleton« TT Interbody Fusion Device, Endoskeleton« TC Interbody Fusion Device, Endoskeleton« TCS Interbody Fusion Device, E 02/11/2019
K100889 TITAN SPINE, LLC ENDOSKELETON TC 07/29/2010
K173535 Titan Spine, LLC Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TAS Hyperlordotic Interbody Fusion Device and Endoskeleton« TCS Interbody Fusion Device 02/13/2018
K092794 TRANSCORP, INC. TRANSCORP ACIF SYSTEM 09/13/2010
K121178 TRANSCORP, INC. TRANSCORP ACIF SYSTEM 07/05/2013
K130573 TYBER MEDICAL LLC TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF 09/30/2013
K182284 Tyber Medical LLC Tyber Medical PT Interbody Spacer 01/18/2019
K172185 Tyber Medical LLC Tyber Medical PT Interbody Spacer System 12/21/2017
K180590 Tyber Medical, LLC Tyber Medical PT Interbody Spacer System 07/06/2018
K132926 U&I CORP. VELOFIXTM INTERBODY FUSION SYSTEM 03/05/2014
K140864 U&I CORP. VELOXTM INTERBODY FUSION SYSTEM 07/22/2014
K190067 U&i Corporation Velofix Interbody Fusion System 02/04/2019
K171749 U&i Corporation Velofix(tm) Interbody Fusion System 07/13/2017
K220696 Ulrich Medical USA uCerv Flux-C 3D Porous Titanium Cervical Interbody 08/19/2022
K082801 US SPINE PHANTOM PLUS CAGE SYSTEM 12/22/2008
K143685 Vertera, Inc. Hedgehog Cervical Interbody Fusion Device 09/23/2015
K230414 Vy Spine, LLC ClariVyÖ Cervical IBF System 05/12/2023
K221162 Vy Spine, LLC UniVy OsteoVy Cervical IBF System 11/04/2022
K223513 Vy Spine, LLC UniVyÖ OsteoVyÖ-Ti Cervical IBF System 04/18/2023
K212715 Vy Spine, LLC Vy Spine ClariVy Cervical IBF System 12/20/2021
K120603 WENZEL SPINE VARILIFT -C 01/29/2013
K111123 WENZEL SPINE VARILIFT CERVICAL INTERBODY FUSION SYSTEM 12/08/2011
K231076 Wenzel Spine, Inc. VariLift«-C Interbody Fusion System 09/27/2023
K112036 X-SPINE SYSTEMS, INC CALIX PC SPINAL IMPLANT SYSTEM 11/08/2011
K083637 X-SPINE SYSTEMS, INC. CALIX SPINAL IMPLANT SYSTEM 04/20/2009
K171075 X-Spine Systems, Inc. Calix-C Cervical Interbody Spacer 08/01/2017
K173832 X-Spine Systems, Inc. InTiceÖ-C Porous Ti Cervical Interbody System 05/17/2018
K140786 XENCO MEDICAL, LLC XENCO MEDICAL CERVICAL INTERBODY SYSTEM 09/03/2014
K152302 Xenco Medical, LLC Xenco Medical Cervical Interbody System (Argus) 09/10/2015
K152987 XENCO MEDICAL, LLC Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System 12/11/2015
K112664 ZAVATION LLC ZAVATION IBF SYSTEMS 12/23/2011
K191354 Zavation Medical Products, LLC Ti3Z Cervical Interbody System 09/09/2019
K202398 Zavation Medical Products, LLC Ti3Z Cervical Interbody System 01/29/2021
K111119 ZIMMER SPINE, INC TRABECULAR METAL (TM) FUSION DEVICE 11/23/2011
K103033 ZIMMER TRABECULAR METAL TECHNOLOGY TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX 01/10/2011
K111983 ZIMMER TRABECULAR METAL TECHNOLOGY VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX 11/18/2011
K133784 ZIMMER TRABECULAR METAL TECHNOLOGY VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION 07/07/2014
K202488 ZSFab Inc. ZSFab Cervical Interbody System 01/07/2021
K232150 ZSFab Inc. ZSFab Cervical Interbody System 08/18/2023


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