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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: GWO FDA class 2

    Plate, Cranioplasty, Preformed, Alterable

    Neurology

    View full classification →

    The Plate, Cranioplasty, Preformed, Alterable is a neurosurgical implant consisting of a preformed, alterable plate used to repair skull defects following craniotomy, trauma, or other conditions requiring cranioplasty, restoring cranial contour and protecting the underlying brain. It is an FDA Class 2 device requiring 510(k) premarket clearance, and it is designated as an implant. Regulated under 21 CFR 882.5320 with product code GWO in the Neurology specialty. This device is classified as an implant.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    TECHFIT Patient-Specific Cranial System
    Fusion Craniofacial Implant; Fusion Skull Implant
    VSP PEEK Cranial Implant
    MCI-Neuro Fixation System
    Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
    Stryker PEEK Customized Cranial Implant Kit
    Optimus NEURO System - Sterile Kit
    Stryker PEEK Customized Cranial Implant Kit
    Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
    Optimus Neuro System
    Universal Mesh - Sterile
    Stryker Universal Mesh
    Sterile NS System
    Stryker Universal Mesh
    Biopor Porous Polyethylene Implants
    PEEK Customized Cranial Implant
    PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
    ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
    OPTIMUS NEURO SYSTEM
    INNOVASIS CRANIAL SYSTEM
    LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
    MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
    UNIVERSAL NEURO 3 SYSTEM
    SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
    NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
    RESORB-X G
    BIOMET MICROFIXATION NEURO PLATING SYSTEM
    PEEK CUSTOMIZED CRAIAL IMPLANT KIT
    STRYKER QUIKFLAP STERILE PROCEDURE PACK
    LEFORTE NEURO SYSTEM BONE PLATE
    STRYKER UNIVERSAL NEURO 3 SYSTEM
    OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
    STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
    FRONTIER DEVICES NEURO SYSTEM
    OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
    SYNTHES (USA) 2.0MM TITANIUM T-PLATE
    SYNTHES CRANIAL SPRING CLIP (CSC)
    TITANIUM MESH
    NEUROSCOPE SEEG
    MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
    RION AUDIOMETER AA-67
    RION AUDIOMETER AA-68

    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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