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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: KWQ FDA class 2

    Appliance, Fixation, Spinal Intervertebral Body

    Orthopedic

    View full classification →

    The Spinal Intervertebral Body Fixation Appliance is an orthopedic implant placed between or around vertebral bodies to restore disc height, provide structural support, or promote spinal fusion, used in the surgical management of degenerative disc disease and spinal instability. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWQ, regulated under 21 CFR 888.3060, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Resolve Anterior Cervical Plate System
    Frida™ Anterior Cervical Plate System
    X-PAC® N-GAGE™ Lumbar Plate System
    Skyway Anterior Cervical Plate System
    Elegance® Anterior Cervical plate
    Cervical Plating System
    OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI
    Skyway Anterior Cervical Plate System
    FlexWing Anterior Cervical Plate System
    Wolff's Law Anterior Cervical Plate System
    icotec Anterior Cervical Plate System
    ARENAL Anterior Cervical Plate System
    MiRus MoRe Lumbar Plating System
    MSFX Mikron Cervical Anterior Plate System
    Alcantara Thoracolumbar Plate System
    TDM Anterior Cervical Plate System
    STRUXXURE® MCS Anterior Cervical Plate System
    uNion® MAX Cervical Plate System
    Curiteva Thoracolumbar Plate System
    Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System
    MONDRIAN™ Anterior Lumbar Plate System
    ADIRA™ Lateral Plate System
    VICTORY™ Lumbar Plate System
    Skyway Anterior Cervical Plate System
    Sapphire X3 Anterior Cervical Plate System
    CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
    FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System
    CODA™ Anterior Cervical Plate System
    Zevo Anterior Cervical Plate System
    Axis Anterior Cervical Plate System
    ATEC Lateral Plate System
    Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System
    Cervical Plate System
    Omnia Medical Coupler-C Anterior Cervical Plate
    Athena III Cervical Plate System
    Magnes-C Anterior Cervical Plate System
    PreView-III™ Anterior Cervical Plate System
    Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
    OAKTREE Anterior Lumbar Plate and Screw System
    CODA™ Anterior Cervical Plate System
    Life Spine ALIF Buttress Plate System
    MONET Anterior Cervical Plate System
    Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate
    FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
    CYGNUS™ MoRe Anterior Cervical Plate System
    VyPlate Anterior Cervical Plate System
    Venus Cervical Plate System
    Cervical Spine Truss System Plating Solution (CSTS-PS)
    Aggeris™-C
    BALTEUM - ONE™ Lumbar Plate 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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