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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: MNH FDA class 2

    Orthosis, Spondylolisthesis Spinal Fixation

    Orthopedic

    View full classification →

    The Orthosis, Spondylolisthesis Spinal Fixation is an orthopedic implant used to stabilize the spine in patients with spondylolisthesis, a condition where one vertebra slips forward over another. It is classified as FDA Class 2, requiring 510(k) premarket notification under 21 CFR 888.3070 in the Orthopedic specialty. The product code is MNH, and the device carries an implant flag indicating it is surgically placed within the body.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Reliance Spinal Screw System
    CastleLoc Spinal Fixation System
    FixxSure® X-Link
    Spinal fixation system
    ANAX™ 5.5 Spinal System
    HC Spinal System
    Zavation Spinal System
    Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
    Spinal Inner Fixation System
    Romeo posterior osteosynthesis system
    CapLOX II/TowerLOX Pedicle Screw System
    Republic Spine Dark Star Spinal System
    PASS LP Spinal System
    ANAX 5.5 Spinal System
    PedFuse Pedicle Screw System
    Ideal pedicle screw spinal system
    CB PROT II Posterior Spinal System
    MAXIMIS SPINAL FIXATION SYSTEM
    KangLi pedical screw spinal system
    GENERAL SPINAL SYSTEM
    SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
    KANGLI PEDICLE SCREW SPINAL SYSTEM
    INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
    COSMOLOCK PEDICLE SCREW SYSTEM
    PLS (POSTERIOR LUMBAR SYSTEM)
    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
    SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
    TRUE SPINAL FUSSION SYSTEM
    PRESSON SPINAL FIXATION SYSTEM
    ANNEXTM ADJACENT LEVEL SYSTEM
    PERFIX ILIAC SCREW SYSTEM
    ANAX 5.5 SPINAL SYSTEM
    OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
    CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
    INTRAMEDULLARY NAIL SYSTEM
    GSO GS1 CANNULATED SCREW SYSTEM
    SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
    MEGA 5.5 SPINE SYSTEM
    INSTINCT JAVA SYSTEM
    GALLEON PEDICLE SCREW SYSTEM
    FORTEX PEDICLE SCREW SYSTEM
    RANGE SPINAL SYSTEM (MESA AND DENALI)
    LDR SPINE SPINETUNE TL SPINAL SYSTEM
    S 100 PEDICLE SCREW SYSTEM
    SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
    DSS STABILIZATION SYSTEM-RIGID
    ARTS2 SPINAL FIXATION SYSTEM
    LANCER PEDICLE SCREW SYSTEM
    XINGTM SPINE 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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