BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960047 · Supplement: S002 · Decision May 1, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    OSTEONICS CONSTRAINED ACETABULAR INSERT
    PMA Number
    P960047
    Supplement Number
    S002
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 1, 2000
    Date Received
    March 24, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the Trident Constrained Acetabular insert design, and the Modified PCA Co Cr, Modified V40 Co Cr, PCA CoCr+15 mm, PCA Zirconia and V40 Zirconia Femoral Heads to the Osteonics Constrained Acetabular Insert PMA.