BEUDAMED
    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P840049 · Decision Sep 30, 1988
    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
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 30, 1988
    Date Received
    October 9, 1984
    Expedited Review
    N
    Docket Number
    88M-0364

    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