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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: NKG FDA class 2

    Posterior Cervical Screw System

    Orthopedic

    View full classification →

    The Posterior Cervical Screw System is an orthopedic implant intended for use in fusion procedures of the cervical spine, craniocervical junction, and/or cervicothoracic junction, indicated for spinal fractures and dislocations, deformities, instabilities, failed fusions, tumors, inflammatory disorders, spinal degeneration, facet degeneration with instability, and reconstruction following decompression for radiculopathy or myelopathy. It may also provide temporary stabilization in patients with cervical spine tumors when life expectancy is insufficient for fusion achievement. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKG and regulation 21 CFR 888.3075 in the Orthopedic specialty. The device is flagged as an implant but is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ANAX™ OCT Spinal System
    Sovereign Posterior Cervical System
    Freedom Posterior Cervical Screws
    Virage® OCT Spinal Fixation System
    EUROPA™ Posterior Cervical Fusion System
    CarboClear® Posterior Cervical Screw System
    QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
    Statera-C™ Spinal System
    Posterior Cervical Spine System
    SYMPHONY OCT System
    VySpan™ PCT System
    NorthStar OCT System
    CastleLoc-S Posterior Cervical Fixation System
    Edge Upper Cervical System
    Cortium™
    VySpan™ PCT System
    INFINITY OCT System
    COSY Cervicothoracic Occipital Rod-Screw System
    Black Diamond™ POCT Spinal System
    NuVasive Reline Cervical System
    Ennovate Cervical Spinal and Occiput System
    M.U.S.T. MINI Posterior Cervical Screws System Extension
    Infinity™ OCT System and PASS OCT Spinal System
    NuVasive Reline Cervical System
    Vy Spine™ VySpan™ PCT System
    Altus Spine Sochi OCT Spinal System
    QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
    Z-LINKPC System
    Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
    Infinity™ OCT System, PASS OCT® Spinal System
    SYMPHONY™ OCT System
    Invictus™ OCT Spinal Fixation System
    M.U.S.T. MINI Posterior Cervical Screws System
    LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
    Centurion POCT System
    Invictus™ CT Spinal Fixation System
    PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
    Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
    Solstice CCI
    VERTICALE® Cervical System
    SYMPHONY™ OCT System
    NorthStar™ OCT Spinal System
    M.U.S.T. MINI Posterior Cervical Screws System
    Yukon OCT Spinal System
    SYPMHONY™ OCT System
    Innovasis Gibralt Spine System
    NuVaisve® Reline® Cervical System
    MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
    Solanas® Posterior OCT Fixation System
    Connector 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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