BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960047 · Supplement: S003 · Decision Jul 25, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT
    PMA Number
    P960047
    Supplement Number
    S003
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 25, 2001
    Date Received
    June 22, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) A DESIGN CHANGE TO THE OUTER BEARING INSERT OF THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT - LATERALIZING THE HEAD CENTER BY 4 MM; 2) THE ADDITION OF ALUMINA FEMORAL HEADS FOR USE WITH THE HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT AND THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT.