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510(k) Data Aggregation

    K Number
    K024022
    Device Name
    OSTEO-CABLE SLEEVE
    Manufacturer
    Date Cleared
    2003-01-23

    (49 days)

    Product Code
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    HXN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as: - Femur And Tibial Fractures . - Prophylactic Banding . - Trochanteric Reattachment . - Olecranon Fractures ● - Patella Fractures ● - Ankle Fractures ● - Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques . - Sternum Fixation After Open Heart Surgery ● - Stabilization Of Cortical Onlay Strut Graft .
    Device Description
    The device modified is the cable sleeve used in the Biomet's BMP™ Cable System (K982545), P/Ns 350805 and 350813/21. No other parts of this system are being modified. The device is machined from a single piece of 316 LVM stainless steel, eliminating assembly of any components. The device profile is in the shape of a wedge with two longitudinal holes that run the length of the part. The holes allow for cables to be passed through during surgery. The narrow end of the wedge has a thin plate to increase surface area. There are small spikes on the bottom of the plate to help eliminate migration of the plate.
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