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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: MAX FDA class 2

    Intervertebral Fusion Device With Bone Graft, Lumbar

    Orthopedic

    View full classification →

    The lumbar intervertebral fusion device with bone graft is an orthopedic implant intended to stabilize spinal segments and promote bony fusion, thereby restricting motion and decreasing pain in patients with lumbar spinal disorders. It is classified as FDA Class II under 21 CFR 888.3080 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MAX and the device carries an implant flag reflecting its surgical placement between vertebral bodies. Full GMP compliance is required.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PathLoc Lumbar Interbody Fusion Cage System
    TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
    aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
    aprevo® posterior/transforaminal lumbar interbody fusion device
    Testa TP Pivoting Spacer System
    X-PAC® LLIF Expandable Lateral Cage System
    X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System
    FIX-L PEEK PLIF and T-PLIF System
    Tera Lumbar Interbody Fusion System (Various PNs)
    FlareHawk Interbody Fusion System
    Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
    ProLift Expandable Spacer System
    Spectrum Spine Lumbar Cage System
    DeGen Medical Patient Specific Implant (PSI) System
    GoLIF! Lumbar Interbody Fusion System
    Tesera-k PL System and Tesera-k XL System
    FortiVy™ OsteoVy™ Lumbar IBF
    IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
    AxCess® Expandable Interbody System
    ProLift Pivot Expandable Spacer System
    Idys® LIF
    DZ-Tabone Intervertebral Body Fusion Device
    Scarlet® AL-T
    BluEX Lumbar Expandable Cage System
    KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System
    ProLift Wedge Expandable Spacer System
    Gemini Medical Cage System
    EARP Interbody System
    IdentiTi™ II Interbody System
    ARTFX Lumbar PEEK Cages
    LumiVy™ Lumbar IBF System
    aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device
    Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
    HAnano InterFuse(R) Modular Interbody
    3D Printed PEEK Interbody System
    Signus Tetris™ St; Signus Tetris™ R St
    IB3D™ PL Spinal System
    COSINE™ Spacer
    Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
    Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology
    aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)
    Solar™ Lumbar Interbody Fusion System
    sagAlign Lumbar Cage System (Various PNs)
    SPIRA® Anterior Lumbar Spacers
    aprevo® TLIF-C Articulating System
    Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System
    Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System
    PILLAR SA Ti Spacer System (82-XXX)
    Reef L Interbody System; WaveForm L Interbody System
    Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF 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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