BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    PMA: P880025 · Supplement: S001 · Decision Feb 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    271
    Registration Numbers
    271

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Trade Name
    DURALOC(TM) 300S ACETABULAR CUP WITH POROCOAT(TM)
    PMA Number
    P880025
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    LPH
    Generic Name
    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 8, 1991
    Date Received
    August 3, 1990
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented