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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: OVD FDA class 2

    Intervertebral Fusion Device With Integrated Fixation, Lumbar

    Orthopedic

    View full classification →

    The Intervertebral Fusion Device with Integrated Fixation, Lumbar (product code OVD) is an implantable orthopedic device intended to stabilize the lumbar spinal segment to promote fusion, restrict motion, and decrease pain using bone graft with or without supplemental fixation. The device integrates fixation hardware directly into the fusion implant, simplifying lumbar interbody fusion procedures. 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
    Anteralign LS coverplate
    MectaLIF 3D Metal Anterior
    SCRIPT™ Implant System
    Ventana™ A Anterior Lumbar Interbody System
    DeGen Medical Patient Specific Implant (PSI) System
    IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
    CONDUIT™ SYNFIX™ Evolution Secured Spacer System
    ProAM ALIF System
    Curiteva Porous PEEK Standalone ALIF System
    OneLIF™ Interbody Fusion System
    Stable-L Lumbar Interbody System
    Ventris Intervertebral Body Fusion Device
    AxTiHA® Stand-Alone ALIF System
    aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
    aprevo® anterior lumbar interbody fusion device with interfixation
    Atlas Spine Lateral Expandable Interbody System
    DeGen Medical Patient Specific Implant (PSI) System
    Catalyft™ LS Expandable Interbody System
    aprevo® anterior lumbar interbody fusion device with interfixation
    Interwedge® Standalone Lateral
    Juliet® Ti LL Lumbar Interbody Device
    E3D™-A Interbody System
    ProAM ALIF System
    Omnia Medical TiBrid™-SA System
    Anterior Spine Truss System-Stand Alone (ASTS-SA)
    E3D™-A Interbody System
    MectaLIF Anterior Lag Extension
    Stable-L Standalone Lumbar Interbody System
    IdentiTi ALIF Interbody Systems
    Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
    MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
    NuVasive Modulus ALIF System
    Zavation ALIF System
    PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
    ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
    Pisces™-SA STANDALONE ALIF Interbody System
    EVOLUTION SPINE Interbody System
    EL CAPITAN Anterior Lumbar Interbody Fusion
    aprevo® anterior lumbar interbody fusion device with interfixation
    MectaLIF Anterior Extension
    NuVasive Cohere ALIF System Intervertebral Body Fusion Device
    Standalone ALIF Interbody Fusion System
    Southern Anterior Screw Fixated Cage (SASCA)
    Align
    SOLO-L
    ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
    PISCES-SA Standalone ALIF Interbody System
    Altus Spine Interbody Standalone Fusion System
    Dakota ALIF System
    EL CAPITAN Anterior Lumbar Interbody Fusion 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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