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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: MNI FDA class 2

    Orthosis, Spinal Pedicle Fixation

    Orthopedic

    View full classification →

    The Orthosis, Spinal Pedicle Fixation is an orthopedic implant used to provide fixation through the pedicles of the vertebrae to stabilize and support the spine. Classified as FDA Class 2 under 21 CFR 888.3070, it requires 510(k) premarket notification demonstrating substantial equivalence. The product code is MNI, reviewed by the Orthopedic panel, and carries an implant flag as it is surgically implanted in the body.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Mikron Spinal Fixation System
    LumFix Spinal Fixation Sytem
    Double Medical Universal Spine System
    MySpine Pedicle Screw Placement Guides - LP
    LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
    Premier
    Sniper (R) Spine System
    YAHUA Spinal System
    FIREFLY Pedicle Screw Navigation Guide
    WASTON General Spinal System
    X-spine Pedicle Screw System
    Gemmed pedicle screw spinal system
    ODALYS Pedicle Screw System
    Reliance Spinal Screw System
    Sniper Spine System
    Sniper Spine System
    DPZ Pedicular Fixation System
    Polyscrew Pedicle Screw System
    PASS LP Spinal System
    NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
    PASS LP SPINAL SYSTEM
    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS
    SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
    MYSPINE PEDICLE SCREW PLACEMENT GUIDES
    GENERAL SPINAL SYSTEM
    AVERSION PEDICLE SCREW SYSTEM
    MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
    EVEREST SPINAL SYSTEM
    ALTUS SPINE PEDICLE SCREW SYSTEM
    TRUE SPINAL FIXATION SYSTEM
    INERTIA MIS PEDICLE SCREW SYSTEM
    EVEREST SPINAL SYSTEM
    LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
    SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
    CORE PEDICLE SCREW SYSTEM
    CAPSURE PS SYSTEM
    SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
    REFORM PEDICLE SCREW SYSTEM
    REFORM PEDICLE SCREW SYSTEM
    RELIANCE SPINAL SCREW SYSTEM
    S-LOK PSS SYSTEM
    CERTEX SPINAL IMPLANT SYSTEM
    TOWERLOX PEDICLE SCREW SYSTEM
    CAPSURE(R) PS SYSTEM
    4CIS VANE SPINE SYSTEM
    REFORM PEDICLE SCREW SYSTEM
    CAPSURE(R) PS SYSTEM
    RANGE SPINAL SYSTEM, UNIT ROD
    LEXUS CERVICAL FIXATION SYSTEM
    RANGE SPINAL SYSTEM (MESA AND DENALI)

    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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