BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P950002 · Supplement: S009 · Decision Apr 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422

    Basic Information

    Device Name
    Intervertebral Fusion Device With Bone Graft, Lumbar
    Trade Name
    BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM
    PMA Number
    P950002
    Supplement Number
    S009
    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
    April 3, 2001
    Date Received
    March 8, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE LABELING OF THE BAK INTERBODY FUSION SYSTEM ADDING A PRECAUTION STATEMENT (IE., THE BAK/PROXIMITY DEVICE IS TO BE USED ONLY IN CONJUNCTINO WITH A STANDARD BAK DEVICE. THE SAFETY AND EFFECTIVENESS OF THE BAK/PROXIMITY DEVICE HAS NOT BEEN ESTABLISHED WHEN USED OTHERWISE.) EFFECTIVE APRIL 1, 2001.

    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