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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: PEK FDA class 2

    Spinous Process Plate

    Orthopedic

    View full classification →

    The Spinous Process Plate is an orthopedic implant designed as a posterior, non-pedicle supplemental fixation device intended for single-level use in the non-cervical spine (T1-S1), typically used to provide additional stabilization in conjunction with anterior lumbar interbody fusion procedures. It falls under the Orthopedic medical specialty and is classified as a Class 2 device under regulation 888.3050, requiring 510(k) premarket notification. As an implanted device, it is subject to general controls and special controls; it is not considered life-sustaining.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3
    Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
    KeyLift™ Expandable Interlaminar Stabilization System
    primaLOK™ SP Interspinous Fusion System
    Huvex Interspinous Fusion System
    Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
    ZIP™ MIS Interspinous Fusion System
    Minuteman G5 MIS Fusion Plate
    Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
    Inspan ScrewLES Fusion System
    Posterior Fusion Plate, HA Posterior Fusion Plate
    CoFix System
    SP-LINK™ System
    AERIAL™ Interspinous Fixation
    SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
    SeaSpine Spinous Process System
    Kalitec Direct InSePtion™ MIS Fixation System
    Huvex Interspinous Fixation System
    HA Minuteman G3-R MIS Fusion Plate
    Z-Clamp ISP System
    coflex-IF
    Spinal Elements' Spinous Process Plate System
    Precision Spine Interspinous Plate System
    Benefix Interspinous Fixation System
    HA Minuteman G3 MIS Fusion Plate
    Precision Spine Interspinous Plate System
    Reliance Interspinous Plate System
    Affix IIS Spinous Process Plate System
    SPINOUS PROCESS FUSION (SPF) PLATE
    Interspinous Plate System
    ZIP MIS INTERSPINOUS FUSION SYSTEM
    AILERON INTERSPINOUS FIXATION SYSTEM
    VIA SPINOUS PROCESS FIXATION SYSTEM
    ROMEO 2 PAD POSTERIOR AXIAL DEVICE
    PFX SPINOUS PROCESS FIXATION SYSTEM
    ZIP MIS INTERSPINOUS FUSION SYSTEM
    INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
    AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
    ZIP MIS INTERSPINOUS FUSION SYSTEM
    SP-FIX SPINOUS PROCESS FIXATION PLATE
    AFFIX II SPINOUS PROCESS PLATE SYSTEM
    UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
    SPECTRUM SPINE SPINOUS PROCESS DEVICE
    INTEGRA INTERSPINOUS PROCESS SYSTEM
    SUREFIX INTERSPINOUS FUSION SYSTEM
    AFFIX SPINOUS PROCESS PLATE SYSTEM
    AXLE INTERSPINOUS FUSION 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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