BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970015 · Supplement: S013 · Decision Jul 11, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INTER FIX THREADED FUSION DEVICE
    PMA Number
    P970015
    Supplement Number
    S013
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 11, 2000
    Date Received
    February 2, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF A POST APPROVAL STUDY FOR THE INTER FIX(TM) THREADED FUSION DEVICE.