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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: GXN FDA class 2

    Plate, Cranioplasty, Preformed, Non-Alterable

    Neurology

    View full classification →

    The Preformed Non-Alterable Cranioplasty Plate is an implanted neurosurgical device used to reconstruct skull defects resulting from trauma, surgery, or disease, providing structural protection to the underlying brain. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant due to its placement within or on the skull. The product code is GXN under regulation 21 CFR 882.5330 in the Neurology specialty. The implant flag is active for this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CustomizedBone Service
    Longeviti ClearFit OTS Cranial Implant
    PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
    MedCAD AccuShape Titanium Patient-Specific Cranial Implant
    Meticuly Patient-Specific Titanium Mesh Implant
    Longeviti ClearFit™ OTS Cranial Implants
    Longeviti PMMA Static Cranial Implant
    Longeviti ClearFit Cranial Implant
    Longeviti ClearFit Cranial Implant
    DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
    CustomizedBone Service
    Longeviti ClearFit Cranial Implant
    OsteoFab Patient Specific Cranial Device
    CustomizedBone Service
    Longeviti PMMA Static Cranial Implant
    CustomizedBone Service
    Cranial PSI
    CustomizedBone Service
    BioArchitects Patient Specific Cranial/Craniofacial Plate
    Patient Contoured Implant-PEEK (PCI-PEEK)
    SPEEDY FLAP SYSTEM
    OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
    OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
    CUSTOM CRANIOFACIAL IMPLANT (CCI)
    CRAINFIX 2 TITANIUM CLAMP SYSTEM
    OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
    MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
    KELYNIAM CUSTOM SKULL IMPLANT (CSI)
    MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
    PATIENT CONTOURED MESH-PEEK (PCM-P)
    MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
    BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
    KLS MARTIN QUICK DISC
    PATIENT CONTOURED MESH (PCM)
    STRYKER CUSTOM TI IMPLANT
    SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
    SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
    CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
    SPIN DOWN RAPIDFLAP
    OSTEOMED CRANIAL FLAP FIXATION SYSTEM
    STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
    MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
    THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
    MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
    LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
    SYNTHES CRANIAL FLAP TUBE CLAMP
    SYNTHES CRANIAL FLAP TWIST CLAMP
    RAPIDFLAP CRANIAL CLAMP
    SEVRAIN CRANIAL CLAMP
    SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)

    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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