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510(k) Data Aggregation

    K Number
    K053557
    Device Name
    ESKA-LIBUR HIP STEM
    Date Cleared
    2006-01-20

    (30 days)

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

    **ESKA IMPLANTS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ESKA-LIBUR Hip Stem is indicated for use in the treatment rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, vascular necrosis, non-union of femoral neck fractures, fracture dislocation of the hip, conversion of unsuccessful arthodeses and revision of previous hip surgeries.
    Device Description
    The ESRA LILOR The stem is available in thirteen sizes with a distal M/L dimension ranging alle 150 5645-4. The Stein 120mm to 180mm. It is modular in nature such that a from 7mm to 19.5mm, and lengals xosal body accepts an adaptor that has male tapers on both ends. One end engages the hip stem and the other a modular head. The distal end of the stem is color buffed while proximal body has the same Spongiosa Metal II® Surface cast into same as the predicate ESKA Modular Hip Stem.
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