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510(k) Data Aggregation

    K Number
    K124027
    Device Name
    MONSTER SCREW SYSTEM
    Manufacturer
    APOGEE ORTHOSOLUTIONS
    Date Cleared
    2013-04-05

    (98 days)

    Product Code
    HWC, HTN
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    APOGEE ORTHOSOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.
    Device Description
    The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available in flat, dome and bowl configurations.
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