BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

    PMA: P820024 · Supplement: S015 · Decision Apr 2, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
    Trade Name
    PROSTHESIS, HIP, HEMI-FEMORAL, METAL
    PMA Number
    P820024
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    LPF
    Generic Name
    Prosthesis, hip, semi-constrained, metal/ceramic/ceramic, cemented
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 2, 1991
    Date Received
    December 12, 1990
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LPF Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented