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510(k) Data Aggregation

    K Number
    K033856
    Device Name
    5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
    Manufacturer
    Date Cleared
    2005-01-07

    (393 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    PETER STEVENS, MD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This pediatric surgical implant is designed for the following intended purposes: - 1. To engage long bones including the femur, tibia, humerus, radius or ulna and permit the bone(s) to be secured to an external fixator or frame via a locking bolt. - 2. Thus to stabilize bone fragments to provide fracture alignment and stability; or - 3. Thus to stabilize bones that have been surgically cut in order to correct deformities including angular, rotational or length discrepancy.
    Device Description
    Not Found
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