BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P950002 · Decision Sep 20, 1996
    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 INTERBODY FUSION SYSTEM
    PMA Number
    P950002
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    September 20, 1996
    Date Received
    January 17, 1995
    Expedited Review
    Y
    Docket Number
    96M-0424

    Advisory Committee Statement

    APPROVAL FOR THE BAK INTERBODY FUSION SYSTEM WITH INSTRUMENTATION.

    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