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510(k) Data Aggregation

    K Number
    K993713
    Device Name
    RIM-FIX, ACETABULAR CUP
    Manufacturer
    SURGICAL IMPLANTS INC.
    Date Cleared
    2000-01-28

    (86 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL IMPLANTS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rim-Fix, acetabular cup system is intended to be used as the pelvic component of a total hip arthroplasty. It can be implanted either as a press fit cup or cemented into the cavity. The acetabular cup is used to restore the acetabular cavity in a total joint arthroplasty and is used in conjunction with a metal femoral hip stem. The indications for use of the Rim-Fix cup system are as follows: Osteoarthritis, rheumatoid arthritis, posttraumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or revision from a failed arthroplasty.
    Device Description
    Rim-Fix, Acetabular Cup
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