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    K Number
    K021039
    Device Name
    BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
    Manufacturer
    DEPUYACROMED
    Date Cleared
    2002-12-11

    (254 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEPUYACROMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
    Device Description
    The BowTi Anterior Buttress Staple System consists of a staple and a screw. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation. The staples have a 5-degree bend, and are available in two sizes, 20mm and 24mm. The self-tapping cancellous screws have a 6.25mm major diameter and are available in lengths of 20mm, 25mm, and 30mm. Both components of BowTi Anterior Buttress Staple System are the manufactured from titanium alloy and have a smooth anodized finish.
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