BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

    PMA: P960054 · Supplement: S003 · Decision Dec 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155

    Basic Information

    Device Name
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
    Trade Name
    S-ROM POLY-DAIL CONSTRAINED LINER
    PMA Number
    P960054
    Supplement Number
    S003
    Device Class
    FDA Class 2
    Product Code
    KWZ
    Generic Name
    Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
    Regulation Number
    888.3310
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 22, 1999
    Date Received
    August 10, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approva for the cleaning and packaging site located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland and the sterilization facility located at ISOTRON plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer