BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    PMA: P910016 · Decision Oct 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
    Trade Name
    NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
    PMA Number
    P910016
    Device Class
    FDA Class 3
    Product Code
    NRA
    Generic Name
    Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 30, 1992
    Date Received
    March 25, 1991
    Expedited Review
    N
    Docket Number
    92M-0446

    Classifications

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

    Product Code Device Name
    NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing