BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P950019 · Supplement: S013 · Decision Jul 15, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422

    Basic Information

    Device Name
    Intervertebral Fusion Device With Bone Graft, Lumbar
    Trade Name
    RAY TFC UNITE PRODUCT LINE
    PMA Number
    P950019
    Supplement Number
    S013
    Device Class
    FDA Class 2
    Product Code
    MAX
    Generic Name
    Intervertebral fusion device with bone graft, lumbar
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 15, 2003
    Date Received
    February 13, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW MANUFACTURING FACILITIES FOR THE RAY TFC UNITE PRODUCT LINE. THE FACILITIES ARE LOCATED AT CENTERPULSE SPINE-TECH, MINNEAPOLIS, MINNESOTA AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MINNESOTA.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar