BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970015 · Supplement: S014 · Decision Aug 9, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INTERFIX THREADED FUSION DEVICE
    PMA Number
    P970015
    Supplement Number
    S014
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 9, 2000
    Date Received
    May 23, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SOFAMOR DANEK MANUFACTURING, WARSAW, INDIANA 46582.