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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: MRW FDA unclassified

    System, Facet Screw Spinal Device

    Unknown

    View full classification →

    The Facet Screw Spinal Device System is an orthopedic spinal implant that uses screws anchored in the facet joints of the vertebrae to provide posterior spinal stabilization, used in spinal fusion and stabilization procedures. This device is currently unclassified by the FDA, meaning its formal regulatory classification has not yet been definitively established. The product code is MRW, reviewed by the Orthopedic panel, and carries an implant flag.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
    Arthrex Spine Compression FT Screw
    The Karma® Fixation System
    AERO MIS Facet Fusion System
    Ion 3D
    zLOCK Lumbar Facet Fixation System
    PMT Posterior Cervical Stabilization System (PCSS)
    Ion 3D
    SC Medica FFX
    zLOCK Lumbar Facet Fixation System
    Ion 3D
    PMT Facet Fixation System, Lumbar (PMT FFS-LX)
    FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
    PMT Expandable Cage (PMT EXP)
    PMT Facet Fixation System (PMT FFS)
    FaSet Fixation System
    Ion Facet Screw System
    CORRIDOR Fixation System
    AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
    PMT Facet Screw
    FaSet Fixation System
    Facet Screw Fixation System
    ALLY™ Facet Screws
    FacetBRIDGE® System
    FacetBRIDGE System
    Facet-Link Stabilization Platform
    Proficient (TM) Facet Screw Spine System
    INTEGRA FACET FIXATION SYSTEM
    SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
    FACET SCREW SYSTEM
    FACET FIXX
    KOMPREDA
    ZYGAFIX SPINAL FACET SCREW SYSTEM
    FACET SCREW SYSTEM
    ILLICO FS FACET FIXATION SYSTEM
    RESOLUTE FACET SCREW SYSTEM
    VENUS FACET SCREW SYSTEM
    Typhoon(TM) Facet Screw Fixation System
    SPARTAN S3 FACET SYSTEM
    RAPTOR FACET FIXATION SYSTEM
    GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
    VIPER F2 FACET FIXATION SYSTEM
    KYPHON ANCHOR FACET SCREW SYSTEM
    PRIMALOK FACET FIXATION SYSTEM
    LANX FACET SCREW SYSTEM
    FACET SCREW SYSTEM
    FIXCET SPINAL FACET SCREW SYSTEM
    SPARTAN S3 FACET SYSTEM
    SPINEOLOGY FACET SCREW
    ZYFUSE FACET FIXATION 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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