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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: KWP FDA class 2

    Appliance, Fixation, Spinal Interlaminal

    Orthopedic

    View full classification →

    The Spinal Interlaminal Fixation Appliance is an orthopedic implant attached to the laminae of adjacent vertebrae to provide posterior spinal stabilization, used in the treatment of spinal instability, deformity, or following decompression surgery. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWP, regulated under 21 CFR 888.3050, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LnK Posterior Cervical Fixation System
    OASYS System
    Sure Lok Mini Posterior Cervical/Upper Thoracic System
    Reliance Posterior Cervical-Thoracic System
    Streamline OCT Occipito-Cervico-Thoracic System
    SOLSTICE OCT System
    SOLSTICE OCT System
    SOLSTICE OCT System
    OASYS System
    Caspian OCT/MESA Mini/DENALI Mini Spinal System
    NEXTGEN ALTIUS OCT SYSTEM
    EXPEDIUM Spine System/Synapse System
    SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
    CASPIAN SPINAL SYSTEM
    CASPIAN OCT SPINAL SYSTEM
    VIRAGE OCT SPINAL FIXATION SYSTEM
    GIBRALT ROD-TO-ROD CROSS CONNECTORS
    STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
    BLACKBIRD SPINAL SYSTEM
    CENTURION POCT SYSTEM
    KESTREL POSTERIOR CERVICAL SPINE SYSTEM
    SYNAPSE SYSTEM
    CERTEX OCT SPINAL IMPLANT SYSTEM
    TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
    MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
    LOTUS
    MOUNTAINEER OCT SPINAL SYSTEM
    LANX SPINAL FIXATION SYSTEM
    VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
    PASS OCT SPINAL SYSTEM
    ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
    VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
    GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
    SPINEOLOGY SPINOUS PROCESS PLATE
    STABILINK MIS SPINAL FIXATION SYSTEM
    VERTEX RECONSTRUCTION SYSTEM
    VERTIFLEX SPINOUS PROCESS FIXATION PLATE
    PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
    RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
    SOLSTICE CROSS CONNECTOR
    NEXTGEN ALTIUS OCT SYSTEM
    RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
    CASIAN, 3.5/4.5 CONNECTORS
    M.U.S.T PEDICLE SCREW SYSTEM
    VERTEX RCCONSTRUCTION SYSTEM
    NEXTGEN ALTIUS OCT SYSTEM
    REXIOUS HOOK FIXATION SYSTEMS
    PIONEER POSTERIOR CERVICO THORACIC SYSTEM
    NEON SYSTEM
    COFLEX-F

    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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