FDA 510(k) Applications for Medical Device Product Code "OVE"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K223362 | 4WEB Medical, Inc. | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 02/02/2023 |
| K231739 | 4Web Medical, Inc. | Cervical Spine Truss System (CSTS) | 09/25/2023 |
| K190870 | 4Web, Inc. | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 08/12/2019 |
| K211111 | Additive Implants, Inc | SureMAX-SA Cervical Standalone System | 07/16/2021 |
| K153629 | Aesculap Implant Systems, Inc. | ArcadiusXP C Spinal System | 05/25/2016 |
| K202812 | Alphatec Spine, Inc. | IdentiTi Cervical Standalone Interbody System | 12/18/2020 |
| K152972 | AMENDIA, INC. | Amendia Stand-Alone Cervical System | 01/14/2016 |
| K101588 | APOLLO SPINE, INC. | ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL | 01/07/2011 |
| K202065 | Astura Medical, LLC | DOLOMITE Anterior Cervical Stabilization System | 10/26/2020 |
| K192570 | Atlas Spine, Inc. | Atlas Spine Expandable Cervical Standalone Interbody System | 02/28/2020 |
| K222903 | BeSpoke Technologies, LLC | Tailored-H Cervical Stand Alone System | 11/18/2022 |
| K152622 | BIOMET SPINE | Alta ACDF System | 07/08/2016 |
| K151064 | BIOMET SPINE | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System | 08/12/2015 |
| K210382 | Blustone Synergy, LLC | Blustone Synergy Diamond SA Cervical System | 07/23/2021 |
| K193153 | Camber Spine Technologies | SPIRA-C Integrated Fixation System | 04/24/2020 |
| K223837 | Camber Spine Technologies | SPIRA«-C Integrated Fixation System | 03/22/2023 |
| K120819 | CENTINEL SPINE, INC. | STALIF C | 08/31/2012 |
| K150053 | Centinel Spine, Inc. | STALIF C; STALIF C-Ti | 06/24/2015 |
| K133200 | CENTINEL SPINE, INC. | STALIF C(R) | 05/08/2014 |
| K142079 | CENTINEL SPINE, INC. | STALIF CTI, STALIF C | 10/24/2014 |
| K152515 | CHOICE SPINE, LP | TOMCAT Cervical Spinal System | 12/18/2015 |
| K170953 | Choice Spine, LP | Tomcat Cervical Spinal System | 04/21/2017 |
| K171489 | Choice Spine, LP. | Acapella Cervical Spacer System | 10/23/2017 |
| K203311 | ChoiceSpine, LLC | ChoiceSpine Blackhawk Ti Cervical Spacer System | 05/10/2021 |
| K223869 | ChoiceSpine, LLC | ChoiceSpine Blackhawk Ti Cervical Spacer System | 09/14/2023 |
| K212562 | Clariance, SA | Idys-C ZP 3DTi | 10/12/2021 |
| K200087 | CoreLink, LLC | F3D Cervical Stand-Alone Interbody Fusion System | 06/15/2020 |
| K211417 | CoreLink, LLC | F3D-C2 Cervical Stand-Alone System | 02/04/2022 |
| K182151 | CTL Medical Corporation | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | 10/11/2018 |
| K223140 | Dio Medical Inc | AEON-CÖ Stand Alone System | 12/20/2022 |
| K113796 | EBI, LLC | SOLITAIRE-C CERVICAL SPACER SYSTEM | 04/26/2012 |
| K213791 | Edisoninno Co., Ltd. | Unispace SA Cervical Cage | 08/05/2022 |
| K190885 | Elevation Spine | Elevation Spine Saber-C System | 08/07/2019 |
| K212853 | Eminent Spine, LLC | Cervical Stand-Alone System | 11/05/2021 |
| K132582 | EXACTECH, INC. | EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM | 02/12/2014 |
| K191489 | Genesys Spine | Genesys Spine 3DP Cervical Interbody System | 01/08/2020 |
| K180056 | Genesys Spine | Genesys Spine AIS-C Cervical Anchored Interbody System | 03/28/2018 |
| K181295 | Genesys Spine | Genesys Spine AIS-C Cervical Stand-Alone System | 08/29/2018 |
| K152099 | GENESYS SPINE | Genesys Spine Apache« Anchored Cervical Interbody Fusion System | 07/28/2016 |
| K083389 | GLOBUS MEDICAL INC. | COALITION SPACER | 03/26/2009 |
| K151939 | GLOBUS MEDICAL INC. | COALITION Spacers | 01/29/2016 |
| K131449 | GLOBUS MEDICAL, INC. | COALITION SPACER | 07/30/2013 |
| K222041 | GS Medical Co. Ltd. | CYGNUS-C Standalone ACIF System | 02/09/2023 |
| K231808 | GS Medical Co. Ltd. | QUASAR Standalone ACIF System | 07/20/2023 |
| K191477 | Huvexel Co., Ltd | AEON-C Stand Alone System | 11/13/2019 |
| K150913 | INCITE INNOVATION | INCITE ANCHORED CERVICAL INTERBODY DEVICE | 04/30/2015 |
| K122008 | INCITE INNOVATION LLC | INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE | 11/16/2012 |
| K130306 | INCITE INNOVATION LLC | INCITE ANCHORED CERVICAL INTERBODY DEVICE | 04/11/2013 |
| K111439 | K2M, INC. | CHESAPEAKE (CERVICAL COMPONENTS) | 08/24/2011 |
| K223105 | Kyocera Medical Technologies, Inc. | Tesera-K SC System | 12/22/2022 |
| K112388 | LANx, Inc | LANX CERVICAL SA | 12/16/2011 |
| K150765 | LDR SPINE USA | LDR Spine ROI-C Cervical Cage System | 09/17/2015 |
| K151934 | LDR SPINE USA | ROI-C Titanium-Coated Implant System | 12/07/2015 |
| K180642 | Life Spine Inc. | Pro-Link« Ti Stand-Alone Cervical Spacer System | 05/10/2018 |
| K121151 | LIFE SPINE, INC | PRO-LINK CERVICAL SPACER SYSTEM | 11/16/2012 |
| K160066 | Life Spine, Inc. | Pro-Link« Stand-Alone Cervical Spacer System | 09/02/2016 |
| K192906 | Medacta International SA | Mecta-C Stand Alone | 03/04/2020 |
| K203076 | Medacta International SA | Mecta-C Stand Alone Extension | 11/06/2020 |
| K210470 | Medicrea International S. A. | C-CURVE Interbody Fusion Device | 09/03/2021 |
| K094042 | MEDTRONIC SOFAMOR DANEK | PEEK PREVAIL CERVICAL INTERBODY DEVICE | 06/30/2010 |
| K113252 | MEDTRONIC SOFAMOR DANEK | PEEK PREVAIL CERVICAL INTERBODY DEVICE | 01/17/2012 |
| K141599 | MEDTRONIC SOFAMOR DANEK USA, INC. | DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM | 01/21/2015 |
| K073285 | MEDTRONIC SOFAMOR DANEK USA, INC. | PEEK PREVAIL CERVICAL INTERBODY DEVICE | 05/15/2008 |
| K223190 | NanoHive Medical LLC | HiveÖ Standalone Cervical System | 12/12/2022 |
| K173077 | NeuroStructures, Inc. | Cavetto-SA Cervical Cage System | 02/23/2018 |
| K200115 | NeuroStructures, Inc. | Cavetto-SA Cervical Cage System | 09/24/2020 |
| K181621 | Nexus Spine, LLC | Stable-C Interbody System | 10/19/2018 |
| K231763 | Nexus Spine, LLC | Stable-C Interbody System | 08/21/2023 |
| K190546 | Nexxt Spine LLC | NEXXT MATRIXX Stand Alone Cervical System | 05/31/2019 |
| K200543 | Nexxt Spine LLC | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | 03/23/2020 |
| K161442 | NUVASIVE INCORPORATED | NuVasive« CoRoent« Small InterlockÖ System | 09/28/2016 |
| K102547 | NUVASIVE, INC. | COROENT INTERLOCK SYSTEM | 02/07/2011 |
| K142299 | NUVASIVE, INCORPORATED | CoRoent Small Interlock System | 11/25/2014 |
| K170961 | NuVasive, Incorporated | NuVasive CoRoent Small Interlock II System | 06/08/2017 |
| K192582 | NuVasive, Incorporated | NuVasive CoRoent Small Interlock System | 11/13/2019 |
| K212612 | Omnia Medical, LLC | Omnia Medical TiBrid-SC | 11/15/2022 |
| K132999 | ORTHOFIX INC. | CERVICAL STAND ALONE SYSTEM | 04/14/2014 |
| K161280 | Orthofix Inc. | Cervical Stand Alone System | 06/17/2016 |
| K170830 | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. | Unison-C Anterior Cervical Fixation System | 06/28/2017 |
| K152793 | PIONEER SURGICAL TECHNOLOGY,INC. DBA RTI SURGICAL, INC. | Unison-C Anterior Cervical Fixation System | 01/19/2016 |
| K203129 | Precision Spine, Inc. | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | 01/12/2021 |
| K163474 | PROVIDENCE MEDICAL TECHNOLOGY, INC. | CAVUX CervicalCage-L SA System | 03/10/2017 |
| K153250 | RENOVIS SURGICAL TECHNOLOGIES | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | 03/16/2016 |
| K111272 | RHAUSLER, INC. | RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM | 11/29/2011 |
| K081194 | RSB SPINE LLC. | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) | 05/29/2008 |
| K162531 | SAFE ORTHOPAEDICS | STERISPINE CC | 12/29/2016 |
| K223143 | Sagico VA USA, LLC | SAGICO Spinal System | 06/26/2023 |
| K221138 | SAGICO VA USA, LLC | Titus Titanium Cervical by SAGICO | 08/04/2023 |
| K161081 | SEASPINE ORTHOPEDICS CORPORATION | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | 09/14/2016 |
| K170569 | SeaSpine Orthopedics Corporation | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | 06/15/2017 |
| K201073 | SeaSpine Orthopedics Corporation | Seaspine WaveForm C Interbody System | 09/18/2020 |
| K212904 | SeaSpine Orthopedics Corporation | SeaSpine WaveForm C Interbody System | 12/14/2021 |
| K213359 | SeaSpine Orthopedics Corporation | SeaSpine WaveForm, C Interbody System | 12/09/2021 |
| K190655 | SeaSpine Orthopedics Corporation | SeaSpine« ShorelineÖ ACS- Anterior Cervical Standalone System | 04/29/2019 |
| K201646 | SeaSpine Orthopedics Corporation | Shoreline ACS (Anterior Cervical System) | 09/14/2020 |
| K092521 | SEASPINE, INC. | ZUMA-C | 04/13/2010 |
| K230608 | Southern Medical (Pty) Ltd | SPICCA Stand-Alone Cervical Fusion Cages | 08/14/2023 |
| K153352 | Spinal Elements Inc. | Vertu« & Vertu« Ti-Bond and Crystal« & Crystal« Ti-Bond Cervical Interbody System | 08/01/2016 |
| K133218 | SPINAL ELEMENTS, INC. | Crystal «; Mosaic «; Vertu « | 12/10/2014 |
| K071833 | SPINAL ELEMENTS, INC. | MOSAIC DEVICES | 10/23/2007 |
| K122771 | SPINAL ELEMENTS, INC. | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | 01/10/2013 |
| K132029 | SPINAL USA | VAULT-C INTERVERTEBRAL BODY FUSION DEVICE | 11/25/2013 |
| K122630 | SPINE SMITH PARTNERS L.P. | IN:C2 SPINAL FIXATION SYSTEM | 12/05/2012 |
| K173175 | Spine Wave, Inc. | Paramount Anterior Cervical Cage System | 11/01/2017 |
| K162760 | SPINE WAVE, INC. | Spine Wave Anterior Cervical Spine System | 02/16/2017 |
| K141314 | SPINEART | SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION | 09/29/2014 |
| K143214 | SPINEART | SCARLET« AC-T Secured Anterior Cervical Cage | 02/23/2015 |
| K172484 | SpineFrontier, Inc. | A-CIFT SoloFuse | 05/08/2018 |
| K151198 | SPINEFRONTIER, INC. | A-CIFT SoloFuse | 07/17/2015 |
| K131880 | SPINEFRONTIER, INC. | SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM | 01/03/2014 |
| K141537 | SPINESMITH HOLDINGS, LLC | IN:C2 SPINAL FIXATION SYSTME | 11/25/2014 |
| K212358 | SpineUp Inc. | Romero Cervical Cage | 01/10/2022 |
| K193000 | SpineVision SAS | Hexanium« ACIF | 10/20/2020 |
| K221578 | SpineVision, S.A.S. | Hexanium ACIF | 11/14/2022 |
| K102606 | STRYKER SPINE | AVS ANCHOR-C CERVICAL CAGE SYSTEM | 04/22/2011 |
| K072415 | SURGICRAFT LTD. | STALIF (TM) C | 01/25/2008 |
| K093762 | SYNTHES SPINE | SYNTHES ZERO-P | 12/20/2010 |
| K072981 | SYNTHES SPINE CO.LP | SYNTHES ZERO-P | 02/11/2008 |
| K112459 | SYNTHES SPINE CO.LP | SYNTHES ZERO-P | 12/12/2011 |
| K112068 | SYNTHES SPINE CO.LP | SYNTHES ZERO-P VARIABLE ANGLE (VA) | 11/07/2011 |
| K121852 | SYNTHES SPINE CO.LP | SYNTHES ZERO-P VARIABLE ANGLE (VA) | 07/25/2012 |
| K102323 | THEKEN SPINE LLC | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE | 12/16/2010 |
| K191565 | Titan Spine, Inc | Endoskeleton TCS Interbody Fusion Device | 08/06/2019 |
| K151596 | TITAN SPINE, LLC | Endoskeleton TCS Interbody Fusion Device | 10/09/2015 |
| K142940 | TITAN SPINE, LLC | Endoskeleton TCS System | 01/28/2015 |
| K153122 | TITAN SPINE, LLC | Endoskeleton(r) TCS System | 12/14/2015 |
| K210573 | U&I Corporation | Velofix SA Cervical Cage | 11/19/2021 |
| K172424 | U&I Corporation | VelofixÖ SA Cervical Cage | 11/22/2017 |
| K131951 | X-SPINE SYSTEMS, INC. | IRIX-C CERVICAL INTEGRATED FUSION SYSTEM | 08/14/2013 |
| K162944 | X-SPINE SYSTEMS, INC. | Irix-C Cervical Integrated Fusion System | 11/07/2016 |
| K160313 | XENCO MEDICAL, LLC | Xenco Medical Cervical Interbody System | 10/21/2016 |
| K223059 | Xenco Medical, LLC | Xenco Medical InterAlign Cervical Interbody System | 06/07/2023 |
| K221049 | Zavation Medical Products, LLC | Zavation VariSync Plate System and VariSync Spacer System | 08/12/2022 |
| K141005 | ZAVATION, LLC | Z-LINK CERVICAL | 08/07/2014 |
| K132894 | ZIMMER SPINE, INC. | OPTIO-C ANTERIOR CERVICAL SYSTEM | 01/16/2014 |
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