BEUDAMED
    Product Code: OVE FDA class 2 21 CFR 888.3080

    Intervertebral Fusion Device With Integrated Fixation, Cervical

    Orthopedic

    The Intervertebral Fusion Device with Integrated Fixation, Cervical (product code OVE) is an implantable orthopedic device intended to stabilize the cervical spinal segment to promote fusion, restrict motion, and decrease pain using bone graft with or without supplemental fixation. It combines the intervertebral spacer and fixation elements into a single integrated device for cervical spine fusion. As an FDA Class 2 device under regulation 888.3080, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    151
    FEI Numbers
    230
    Registration Numbers
    230
    Unique Applicants
    110
    Years Active
    18

    Basic Information

    Product Code
    OVE
    Device Class
    FDA class 2
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 151 510(k) clearances via K numbers.

    K Number Device Name
    K251431 FIX-C PEEK ACIF SA System
    K251117 Cervical Spine Truss System (CSTS)
    K242928 Tesera-k SC System
    K243188 CYLOX® ST
    K242483 Genesys Spine AIS-C II Cervical Interbody Fusion System
    K242517 ProAM ACDF System
    K241846 E3D™-C Interbody System
    K241467 Stable-C Interbody System
    K240699 SCARLET® AC-Ti
    K234119 UniSpace® Stand-Alone C Cage
    K240715 Idys® C ZP 3DTi
    K233594 Genesys Spine 3DP AIS-C II Cervical Interbody System
    K233414 Shoreline ACS Interbody System; Shoreline RT Interbody System
    K233191 TotalTi ACDF by SAGICO
    K232348 RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
    K231704 Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
    K231739 Cervical Spine Truss System (CSTS)
    K223869 ChoiceSpine Blackhawk Ti Cervical Spacer System
    K231763 Stable-C Interbody System
    K230608 SPICCA Stand-Alone Cervical Fusion Cages
    K221138 Titus Titanium Cervical by SAGICO
    K231808 QUASAR Standalone ACIF System
    K223143 SAGICO Spinal System
    K223059 Xenco Medical InterAlign Cervical Interbody System
    K223837 SPIRA®-C Integrated Fixation System
    K222041 CYGNUS-C Standalone ACIF System
    K223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
    K223105 Tesera-K SC System
    K223140 AEON-C™ Stand Alone System
    K223190 Hive™ Standalone Cervical System
    K222903 Tailored-H Cervical Stand Alone System
    K212612 Omnia Medical TiBrid-SC
    K221578 Hexanium ACIF
    K221049 Zavation VariSync Plate System and VariSync Spacer System
    K213791 Unispace SA Cervical Cage
    K211417 F3D-C2 Cervical Stand-Alone System
    K212358 Romero Cervical Cage
    K212904 SeaSpine WaveForm C Interbody System
    K213359 SeaSpine WaveForm, C Interbody System
    K210573 Velofix SA Cervical Cage
    K212853 Cervical Stand-Alone System
    K212562 Idys-C ZP 3DTi
    K210470 C-CURVE Interbody Fusion Device
    K210382 Blustone Synergy Diamond SA Cervical System
    K211111 SureMAX-SA Cervical Standalone System
    K203311 ChoiceSpine Blackhawk Ti Cervical Spacer System
    K203129 NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
    K202812 IdentiTi Cervical Standalone Interbody System
    K203076 Mecta-C Stand Alone Extension
    K202065 DOLOMITE Anterior Cervical Stabilization System
    K193000 Hexanium® ACIF
    K200115 Cavetto-SA Cervical Cage System
    K201073 Seaspine WaveForm C Interbody System
    K201646 Shoreline ACS (Anterior Cervical System)
    K200087 F3D Cervical Stand-Alone Interbody Fusion System
    K193153 SPIRA-C Integrated Fixation System
    K200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
    K192906 Mecta-C Stand Alone
    K192570 Atlas Spine Expandable Cervical Standalone Interbody System
    K191489 Genesys Spine 3DP Cervical Interbody System
    K192582 NuVasive CoRoent Small Interlock System
    K191477 AEON-C Stand Alone System
    K190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)
    K190885 Elevation Spine Saber-C System
    K191565 Endoskeleton TCS Interbody Fusion Device
    K190546 NEXXT MATRIXX Stand Alone Cervical System
    K190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
    K181621 Stable-C Interbody System
    K182151 MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
    K181295 Genesys Spine AIS-C Cervical Stand-Alone System
    K180642 Pro-Link® Ti Stand-Alone Cervical Spacer System
    K172484 A-CIFT SoloFuse
    K180056 Genesys Spine AIS-C Cervical Anchored Interbody System
    K173077 Cavetto-SA Cervical Cage System
    K172424 Velofix™ SA Cervical Cage
    K173175 Paramount Anterior Cervical Cage System
    K171489 Acapella Cervical Spacer System
    K170830 Unison-C Anterior Cervical Fixation System
    K170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone System
    K170961 NuVasive CoRoent Small Interlock II System
    K170953 Tomcat Cervical Spinal System
    K163474 CAVUX CervicalCage-L SA System
    K162760 Spine Wave Anterior Cervical Spine System
    K162531 STERISPINE CC
    K162944 Irix-C Cervical Integrated Fusion System
    K160313 Xenco Medical Cervical Interbody System
    K161442 NuVasive® CoRoent® Small Interlock™ System
    K161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone System
    K160066 Pro-Link® Stand-Alone Cervical Spacer System
    K153352 Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
    K152099 Genesys Spine Apache® Anchored Cervical Interbody Fusion System
    K152622 Alta ACDF System
    K161280 Cervical Stand Alone System
    K153629 ArcadiusXP C Spinal System
    K153250 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
    K151939 COALITION Spacers
    K152793 Unison-C Anterior Cervical Fixation System
    K152972 Amendia Stand-Alone Cervical System
    K152515 TOMCAT Cervical Spinal System
    K153122 Endoskeleton(r) TCS System
    K151934 ROI-C Titanium-Coated Implant System
    K151596 Endoskeleton TCS Interbody Fusion Device
    K150765 LDR Spine ROI-C Cervical Cage System
    K151064 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
    K151198 A-CIFT SoloFuse
    K150053 STALIF C; STALIF C-Ti
    K150913 INCITE ANCHORED CERVICAL INTERBODY DEVICE
    K143214 SCARLET® AC-T Secured Anterior Cervical Cage
    K142940 Endoskeleton TCS System
    K141599 DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
    K133218 Crystal ®; Mosaic ®; Vertu ®
    K142299 CoRoent Small Interlock System
    K141537 IN:C2 SPINAL FIXATION SYSTME
    K142079 STALIF CTI, STALIF C
    K141314 SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
    K141005 Z-LINK CERVICAL
    K133200 STALIF C(R)
    K132999 CERVICAL STAND ALONE SYSTEM
    K132582 EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
    K132894 OPTIO-C ANTERIOR CERVICAL SYSTEM
    K131880 SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
    K132029 VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
    K131951 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
    K131449 COALITION SPACER
    K130306 INCITE ANCHORED CERVICAL INTERBODY DEVICE
    K122771 SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
    K122630 IN:C2 SPINAL FIXATION SYSTEM
    K122008 INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
    K121151 PRO-LINK CERVICAL SPACER SYSTEM
    K120819 STALIF C
    K121852 SYNTHES ZERO-P VARIABLE ANGLE (VA)
    K113796 SOLITAIRE-C CERVICAL SPACER SYSTEM
    K113252 PEEK PREVAIL CERVICAL INTERBODY DEVICE
    K112388 LANX CERVICAL SA
    K112459 SYNTHES ZERO-P
    K111272 RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
    K112068 SYNTHES ZERO-P VARIABLE ANGLE (VA)
    K111439 CHESAPEAKE (CERVICAL COMPONENTS)
    K102606 AVS ANCHOR-C CERVICAL CAGE SYSTEM
    K102547 COROENT INTERLOCK SYSTEM
    K101588 ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
    K093762 SYNTHES ZERO-P
    K102323 CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
    K094042 PEEK PREVAIL CERVICAL INTERBODY DEVICE
    K092521 ZUMA-C
    K083389 COALITION SPACER
    K081194 INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
    K073285 PEEK PREVAIL CERVICAL INTERBODY DEVICE
    K072981 SYNTHES ZERO-P
    K072415 STALIF (TM) C
    K071833 MOSAIC DEVICES

    FEI Numbers

    This FDA classification entry is associated with 230 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 230 registration numbers. Click on an entry to view related FDA registrations.