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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OVE FDA class 2

    Intervertebral Fusion Device With Integrated Fixation, Cervical

    Orthopedic

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FIX-C PEEK ACIF SA System
    Cervical Spine Truss System (CSTS)
    Tesera-k SC System
    CYLOX® ST
    Genesys Spine AIS-C II Cervical Interbody Fusion System
    ProAM ACDF System
    E3D™-C Interbody System
    Stable-C Interbody System
    SCARLET® AC-Ti
    UniSpace® Stand-Alone C Cage
    Idys® C ZP 3DTi
    Genesys Spine 3DP AIS-C II Cervical Interbody System
    Shoreline ACS Interbody System; Shoreline RT Interbody System
    TotalTi ACDF by SAGICO
    RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
    Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
    Cervical Spine Truss System (CSTS)
    ChoiceSpine Blackhawk Ti Cervical Spacer System
    Stable-C Interbody System
    SPICCA Stand-Alone Cervical Fusion Cages
    Titus Titanium Cervical by SAGICO
    QUASAR Standalone ACIF System
    SAGICO Spinal System
    Xenco Medical InterAlign Cervical Interbody System
    SPIRA®-C Integrated Fixation System
    CYGNUS-C Standalone ACIF System
    Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
    Tesera-K SC System
    AEON-C™ Stand Alone System
    Hive™ Standalone Cervical System
    Tailored-H Cervical Stand Alone System
    Omnia Medical TiBrid-SC
    Hexanium ACIF
    Zavation VariSync Plate System and VariSync Spacer System
    Unispace SA Cervical Cage
    F3D-C2 Cervical Stand-Alone System
    Romero Cervical Cage
    SeaSpine WaveForm C Interbody System
    SeaSpine WaveForm, C Interbody System
    Velofix SA Cervical Cage
    Cervical Stand-Alone System
    Idys-C ZP 3DTi
    C-CURVE Interbody Fusion Device
    Blustone Synergy Diamond SA Cervical System
    SureMAX-SA Cervical Standalone System
    ChoiceSpine Blackhawk Ti Cervical Spacer System
    NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
    IdentiTi Cervical Standalone Interbody System
    Mecta-C Stand Alone Extension
    DOLOMITE Anterior Cervical Stabilization System

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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