BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970015 · Supplement: S009 · Decision Apr 12, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INTER FIX RP THREADED FUSION DEVICE
    PMA Number
    P970015
    Supplement Number
    S009
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 12, 2000
    Date Received
    October 7, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the 22 and 24 mm Diameter Inter Fix RP Threaded Fusion Device.