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510(k) Data Aggregation

    K Number
    K192162
    Device Name
    NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
    Manufacturer
    NeuroVention LLC
    Date Cleared
    2020-03-13

    (217 days)

    Product Code
    GXR, GWO, HBW
    Regulation Number
    882.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroVention LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
    Device Description
    The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.
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    K Number
    K121276
    Device Name
    NEURO VENTION LAMINPLASTY PLATING SYSTEM
    Manufacturer
    NEUROVENTION LLC
    Date Cleared
    2012-08-29

    (124 days)

    Product Code
    NQW, NOW
    Regulation Number
    888.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROVENTION LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroVention LamiFix Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The NeuroVention LamiFix Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
    Device Description
    The NeuroVention LamiFix Laminoplasty Plating System is comprised of various sized, pre-bent miniplates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at the center and both ends of the plate to allow for attachment to the bone. The center hole in the plate is used for attachment to bone allograft spacers that are provided in a variety of sizes. The screws intended for use with the mini-plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
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