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510(k) Data Aggregation

    K Number
    K010869
    Device Name
    EPOCA CUSTOM OFFSET SHOULDER SYSTEM
    Manufacturer
    ARGOMEDICAL AG
    Date Cleared
    2001-10-11

    (202 days)

    Product Code
    KWT
    Regulation Number
    888.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARGOMEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EPOCA Custom Offset Hemi-Shoulder System is a single-use device intended for cemented reconstruction of the humeral portion of severely destroyed (4-part fractures) and/or disabled and/or very painful shoulder joints resulting from osteoarthritis, rheumatoid-arthritis, traumatic arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present. This device is intended for use with components of the EPOCA Custom Offset Hemi-Shoulder System only.
    Device Description
    Not Found
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