BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

    PMA: P840049 · Supplement: S001 · Decision Sep 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127

    Basic Information

    Device Name
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
    Trade Name
    P.C.A.(TM) TOTAL KNEE SYSTEM
    PMA Number
    P840049
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    HRY
    Generic Name
    PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 10, 1991
    Date Received
    May 3, 1989
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer