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 |