OVE · Intervertebral Fusion Device With Integrated Fixation, Cervical
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | OVE |
|---|---|
| Device Name | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Classification Rationale
(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Cleared Devices (158)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | Apr 15, 2026 | SESE |
| K260038 | E3D-C Interbody System | Evolution Spine | Feb 4, 2026 | SESE |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Globus Medical, Inc. | Dec 22, 2025 | SESE |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | Dec 11, 2025 | SESE |
| K250076 | Endeavor Stand-Alone Cervical IBF System | Innovasis | Sep 25, 2025 | SESE |
| K250540 | SABER-C System | Elevation Spine | Aug 8, 2025 | SESE |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | Jul 30, 2025 | SESE |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | Jun 27, 2025 | SESE |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | Apr 25, 2025 | SESE |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | Apr 10, 2025 | SESE |
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | Feb 11, 2025 | SESE |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | Feb 7, 2025 | SESE |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | Nov 20, 2024 | SESE |
| K241846 | E3D-C Interbody System | Evolution Spine | Aug 12, 2024 | SESE |
| K241467 | Stable-C Interbody System | Nexus Spine, LLC | Jul 17, 2024 | SESE |
| K240699 | SCARLET® AC-Ti | Spineart SA | May 10, 2024 | SESE |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | Apr 19, 2024 | SESE |
| K240715 | Idys® C ZP 3DTi | Clariance | Mar 22, 2024 | SESE |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | Dec 13, 2023 | SESE |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | Nov 28, 2023 | SESE |
| K233191 | TotalTi ACDF by SAGICO | Spinal Analytics & Geometrical Implant Co, LLC | Nov 21, 2023 | SESE |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System | MiRus, LLC | Oct 27, 2023 | SESE |
| K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | Life Spine, Inc. | Oct 19, 2023 | SESE |
| K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | Sep 25, 2023 | SESE |
| K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | Sep 14, 2023 | SESE |
| K231763 | Stable-C Interbody System | Nexus Spine, LLC | Aug 21, 2023 | SESE |
| K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | Aug 14, 2023 | SESE |
| K221138 | Titus Titanium Cervical by SAGICO | Sagico VA USA, LLC | Aug 4, 2023 | SESE |
| K231808 | QUASAR Standalone ACIF System | GS Medical Co., Ltd. | Jul 20, 2023 | SESE |
| K223143 | SAGICO Spinal System | Sagico VA USA, LLC | Jun 26, 2023 | SESE |
| K223059 | Xenco Medical InterAlign Cervical Interbody System | Xenco Medical, LLC | Jun 7, 2023 | SESE |
| K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | Mar 22, 2023 | SESE |
| K222041 | CYGNUS-C Standalone ACIF System | GS Medical Co., Ltd. | Feb 9, 2023 | SESE |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | Feb 2, 2023 | SESE |
| K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | Dec 22, 2022 | SESE |
| K223140 | AEON-C Stand Alone System | Dio Medical, Inc. | Dec 20, 2022 | SESE |
| K223190 | Hive Standalone Cervical System | NanoHive Medical, LLC | Dec 12, 2022 | SESE |
| K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies, LLC | Nov 18, 2022 | SESE |
| K212612 | Omnia Medical TiBrid-SC | Omnia Medical, LLC | Nov 15, 2022 | SESE |
| K221578 | Hexanium ACIF | Spinevision, S.A.S. | Nov 14, 2022 | SESE |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | Aug 12, 2022 | SESE |
| K213791 | Unispace SA Cervical Cage | Edisoninno Co., Ltd. | Aug 5, 2022 | SESE |
| K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | Feb 4, 2022 | SESE |
| K212358 | Romero Cervical Cage | Spineup, Inc. | Jan 10, 2022 | SESE |
| K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | Dec 14, 2021 | SESE |
| K213359 | SeaSpine WaveForm, C Interbody System | SeaSpine Orthopedics Corporation | Dec 9, 2021 | SESE |
| K210573 | Velofix SA Cervical Cage | U&I Corporation | Nov 19, 2021 | SESE |
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | Nov 5, 2021 | SESE |
| K212562 | Idys-C ZP 3DTi | Clariance, SA | Oct 12, 2021 | SESE |
| K210470 | C-CURVE Interbody Fusion Device | Medicrea International SA | Sep 3, 2021 | SESE |
| K210382 | Blustone Synergy Diamond SA Cervical System | Blustone Synergy, LLC | Jul 23, 2021 | SESE |
| K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | Jul 16, 2021 | SESE |
| K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | May 10, 2021 | SESE |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | Precision Spine, Inc. | Jan 12, 2021 | SESE |
| K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | Dec 18, 2020 | SESE |
| K203076 | Mecta-C Stand Alone Extension | Medacta International S.A. | Nov 6, 2020 | SESE |
| K202065 | DOLOMITE Anterior Cervical Stabilization System | Astura Medical, LLC | Oct 26, 2020 | SESE |
| K193000 | Hexanium® ACIF | Spinevision, S.A.S. | Oct 20, 2020 | SESE |
| K200115 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | Sep 24, 2020 | SESE |
| K201073 | Seaspine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | Sep 18, 2020 | SESE |
| K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | Sep 14, 2020 | SESE |
| K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | Jun 15, 2020 | SESE |
| K193153 | SPIRA-C Integrated Fixation System | Camber Spine Technologies | Apr 24, 2020 | SESE |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | Mar 23, 2020 | SESE |
| K192906 | Mecta-C Stand Alone | Medacta International S.A. | Mar 4, 2020 | SESE |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | Atlas Spine, Inc. | Feb 28, 2020 | SESE |
| K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | Jan 8, 2020 | SESE |
| K192582 | NuVasive CoRoent Small Interlock System | Nu Vasive, Incorporated | Nov 13, 2019 | SESE |
| K191477 | AEON-C Stand Alone System | Huvexel Co. , Ltd. | Nov 13, 2019 | SESE |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4Web, Inc. | Aug 12, 2019 | SESE |
| K190885 | Elevation Spine Saber-C System | Elevation Spine | Aug 7, 2019 | SESE |
| K191565 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, Inc. | Aug 6, 2019 | SESE |
| K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | May 31, 2019 | SESE |
| K190655 | SeaSpine® Shoreline ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | Apr 29, 2019 | SESE |
| K181621 | Stable-C Interbody System | Nexus Spine, LLC | Oct 19, 2018 | SESE |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | Ctl Medical Corporation | Oct 11, 2018 | SESE |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Genesys Spine | Aug 29, 2018 | SESE |
| K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | Life Spine, Inc. | May 10, 2018 | SESE |
| K172484 | A-CIFT SoloFuse | Spinefrontier, Inc. | May 8, 2018 | SESE |
| K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | Genesys Spine | Mar 28, 2018 | SESE |
| K173077 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | Feb 23, 2018 | SESE |
| K172424 | Velofix SA Cervical Cage | U&I Corporation | Nov 22, 2017 | SESE |
| K173175 | Paramount Anterior Cervical Cage System | Spine Wave, Inc. | Nov 1, 2017 | SESE |
| K171489 | Acapella Cervical Spacer System | Choicespine, LP | Oct 23, 2017 | SESE |
| K170830 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | Jun 28, 2017 | SESE |
| K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | Jun 15, 2017 | SESE |
| K170961 | NuVasive CoRoent Small Interlock II System | Nu Vasive, Incorporated | Jun 8, 2017 | SESE |
| K170953 | Tomcat Cervical Spinal System | Choicespine, LP | Apr 21, 2017 | SESE |
| K163474 | CAVUX CervicalCage-L SA System | Providence Medical Technology, Inc. | Mar 10, 2017 | SESE |
| K162760 | Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | Feb 16, 2017 | SESE |
| K162531 | STERISPINE CC | Safe Orthopaedics | Dec 29, 2016 | SESE |
| K162944 | Irix-C Cervical Integrated Fusion System | X-Spine Systems, Inc. | Nov 7, 2016 | SESE |
| K160313 | Xenco Medical Cervical Interbody System | Xenco Medical, LLC | Oct 21, 2016 | SESE |
| K161442 | NuVasive® CoRoent® Small Interlock System | Nu Vasive, Incorporated | Sep 28, 2016 | SESE |
| K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | Sep 14, 2016 | SESE |
| K160066 | Pro-Link® Stand-Alone Cervical Spacer System | Life Spine, Inc. | Sep 2, 2016 | SESE |
| K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System | Spinal Elements, Inc. | Aug 1, 2016 | SESE |
| K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion System | Genesys Spine | Jul 28, 2016 | SESE |
| K152622 | Alta ACDF System | Biomet Spine | Jul 8, 2016 | SESE |
| K161280 | Cervical Stand Alone System | Orthofix, Inc. | Jun 17, 2016 | SESE |
| K153629 | ArcadiusXP C Spinal System | Aesculap Implant Systems, Inc. | May 25, 2016 | SESE |
| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | Renovis Surgical Technologies | Mar 16, 2016 | SESE |
| K151939 | COALITION Spacers | Globus Medical, Inc. | Jan 29, 2016 | SESE |
| K152793 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | Jan 19, 2016 | SESE |
| K152972 | Amendia Stand-Alone Cervical System | Amendia, Inc. | Jan 14, 2016 | SESE |
| K152515 | TOMCAT Cervical Spinal System | Choicespine, LP | Dec 18, 2015 | SESE |
| K153122 | Endoskeleton(r) TCS System | Titan Spine, LLC | Dec 14, 2015 | SESE |
| K151934 | ROI-C Titanium-Coated Implant System | Ldr Spine USA | Dec 7, 2015 | SESE |
| K151596 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, LLC | Oct 9, 2015 | SESE |
| K150765 | LDR Spine ROI-C Cervical Cage System | Ldr Spine USA | Sep 17, 2015 | SESE |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System | Biomet Spine | Aug 12, 2015 | SESE |
| K151198 | A-CIFT SoloFuse | Spinefrontier, Inc. | Jul 17, 2015 | SESE |
| K150053 | STALIF C; STALIF C-Ti | Centinel Spine, Inc. | Jun 24, 2015 | SESE |
| K150913 | INCITE ANCHORED CERVICAL INTERBODY DEVICE | Incite Innovation | Apr 30, 2015 | SESE |
| K143214 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | Feb 23, 2015 | SESE |
| K142940 | Endoskeleton TCS System | Titan Spine, LLC | Jan 28, 2015 | SESE |
| K141599 | DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM | Medtronic Sofamor Danek USA, Inc. | Jan 21, 2015 | SESE |
| K133218 | Crystal ®; Mosaic ®; Vertu ® | Spinal Elements, Inc. | Dec 10, 2014 | SESE |
| K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | Nov 25, 2014 | SESE |
| K141537 | IN:C2 SPINAL FIXATION SYSTME | Spine Smith Holdings, LLC | Nov 25, 2014 | SESE |
| K142079 | STALIF CTI, STALIF C | Centinel Spine, Inc. | Oct 24, 2014 | SESE |
| K141314 | SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION | Spineart | Sep 29, 2014 | SESE |
| K141005 | Z-LINK CERVICAL | Zavation, LLC | Aug 7, 2014 | SESE |
| K133200 | STALIF C(R) | Centinel Spine, Inc. | May 8, 2014 | SESE |
| K132999 | CERVICAL STAND ALONE SYSTEM | Orthofix, Inc. | Apr 14, 2014 | SESE |
| K132582 | EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM | Exactech, Inc. | Feb 12, 2014 | SESE |
| K132894 | OPTIO-C ANTERIOR CERVICAL SYSTEM | Zimmer Spine, Inc. | Jan 16, 2014 | SESE |
| K131880 | SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM | Spinefrontier, Inc. | Jan 3, 2014 | SESE |
| K132029 | VAULT-C INTERVERTEBRAL BODY FUSION DEVICE | Spinal USA | Nov 25, 2013 | SESE |
| K131951 | IRIX-C CERVICAL INTEGRATED FUSION SYSTEM | X-Spine Systems, Inc. | Aug 14, 2013 | SESE |
| K131449 | COALITION SPACER | Globus Medical, Inc. | Jul 30, 2013 | SESE |
| K130306 | INCITE ANCHORED CERVICAL INTERBODY DEVICE | Incite Innovation, LLC | Apr 11, 2013 | SESE |
| K122771 | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | Spinal Elements, Inc. | Jan 10, 2013 | SESE |
| K122630 | IN:C2 SPINAL FIXATION SYSTEM | Spine Smith Partners L.P. | Dec 5, 2012 | SESE |
| K122008 | INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE | Incite Innovation, LLC | Nov 16, 2012 | SESE |
| K121151 | PRO-LINK CERVICAL SPACER SYSTEM | Life Spine, Inc. | Nov 16, 2012 | SESE |
| K120819 | STALIF C | Centinel Spine, Inc. | Aug 31, 2012 | SESE |
| K121852 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | Synthes Spine Co.Lp | Jul 25, 2012 | SESE |
| K113796 | SOLITAIRE-C CERVICAL SPACER SYSTEM | Ebi, LLC | Apr 26, 2012 | SESE |
| K113252 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | Medtronic Sofamor Danek | Jan 17, 2012 | SESE |
| K112388 | LANX CERVICAL SA | Lanx, Inc. | Dec 16, 2011 | SESE |
| K112459 | SYNTHES ZERO-P | Synthes Spine Co.Lp | Dec 12, 2011 | SESE |
| K111272 | RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM | Rhausler, Inc. | Nov 29, 2011 | SESE |
| K112068 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | Synthes Spine Co.Lp | Nov 7, 2011 | SESE |
| K111439 | CHESAPEAKE (CERVICAL COMPONENTS) | K2m, Inc. | Aug 24, 2011 | SESE |
| K102606 | AVS ANCHOR-C CERVICAL CAGE SYSTEM | Stryker Spine | Apr 22, 2011 | SESE |
| K102547 | COROENT INTERLOCK SYSTEM | Nuvasive, Inc. | Feb 7, 2011 | SESE |
| K101588 | ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL | Apollo Spine, Inc. | Jan 7, 2011 | SESE |
| K093762 | SYNTHES ZERO-P | Synthes Spine | Dec 20, 2010 | SESE |
| K102323 | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE | Theken Spine, LLC | Dec 16, 2010 | SESE |
| K094042 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | Medtronic Sofamor Danek | Jun 30, 2010 | SESE |
| K092521 | ZUMA-C | Seaspine, Inc. | Apr 13, 2010 | SESE |
| K083389 | COALITION SPACER | Globus Medical, Inc. | Mar 26, 2009 | SESE |
| K081194 | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) | Rsb Spine, LLC | May 29, 2008 | SESE |
| K073285 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | Medtronic Sofamor Danek USA, Inc. | May 15, 2008 | SESE |
| K072981 | SYNTHES ZERO-P | Synthes Spine Co.Lp | Feb 11, 2008 | SESE |
| K072415 | STALIF (TM) C | Surgicraft , Ltd. | Jan 25, 2008 | SESE |
| K071833 | MOSAIC DEVICES | Spinal Elements, Inc. | Oct 23, 2007 | SESE |
Top Applicants
- SeaSpine Orthopedics Corporation — 8 clearances
- Genesys Spine — 6 clearances
- Synthes Spine Co.Lp — 4 clearances
- Spinal Elements, Inc. — 4 clearances
- Nu Vasive, Incorporated — 4 clearances
