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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: ODP FDA class 2

    Intervertebral Fusion Device With Bone Graft, Cervical

    Orthopedic

    View full classification →

    The Intervertebral Fusion Device with Bone Graft for Cervical Spine (product code ODP) is an orthopedic implant used to stabilize the cervical spinal segment and promote fusion, thereby restricting motion and decreasing pain; it incorporates bone graft to facilitate the fusion process. The device is placed in the disc space following discectomy at one or more cervical levels. This device is FDA Class 2 under regulation 888.3080 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag indicating it remains in the body permanently. It carries no life-sustaining flag.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BluEX Cervical Expandable Cage System
    OSTEOMNI SPINAL CAGES SYSTEM
    ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
    ORIO-3D Cage System
    HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
    MOD-C
    Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
    Flex-Z™ Cervical Cage
    Hive™ Standalone Cervical System and Hive™ C Interbody System
    Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
    Curiteva Porous PEEK Cervical Interbody Fusion System
    Cervical Interbody and VBR Fusion System
    Advantage-C™ Ti3D Cervical Interbody Fusion Device
    aprevo® cervical interbody system
    MSFX MIKRON PEEK CAGES
    SpineLinc Anterior Cervical Implant System
    Dakota LP System
    EffortMed PEEK Cages & Corpectomy Cages
    BEE HA
    DeGen Medical Latitude-C AM Cervical Interbody Fusion System
    IVA & AEON Cervical and Lumbar Cage System
    IdentiTi II Cervical Interbody System
    EVOL® ha – Hyper C Cervical Interbody Fusion System
    FIX-C 3D Ti ACIF System
    Xenco Medical CancelleX Cervical Interbody System
    aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
    ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
    Gemini Cervical Fusion Cage System
    PYXIS 3D Titanium Cervical Cage system
    ARTFX MEDICAL Cervical PEEK Cages
    Spectrum Spine Cervical Cage System
    uCerv Flux™-C 3D Porous Titanium Cervical Interbody
    MATRIX HA PEEK Cervical IBF System
    Tranquil-C Interbody System
    BEE Cervical Cage
    Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
    Align Cervical Interbody Fusion System
    Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
    ClariVy™ Cervical IBF System
    Acro Composites Interbody System
    HAtetracell™-C Titanium Cervical IBF System
    Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
    VariLift®-C Interbody Fusion System
    neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
    ZSFab Cervical Interbody System
    SPICCA Cervical Fusion Cages
    CarboClear Cervical Cage System, CarboClear Cervical VBR System
    NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System
    Integral Titanium Cervical Interbody
    F3D Interbody 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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