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510(k) Data Aggregation

    K Number
    K023375
    Device Name
    MODIFICATION TO ESOP CO-CR FEMORAL HEADS
    Date Cleared
    2002-10-25

    (17 days)

    Product Code
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO-ACTIVE HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
    Device Description
    The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameters for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameters.
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