BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P000028 · Supplement: S006 · Decision Aug 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422

    Basic Information

    Device Name
    Intervertebral Fusion Device With Bone Graft, Lumbar
    Trade Name
    AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
    PMA Number
    P000028
    Supplement Number
    S006
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 24, 2004
    Date Received
    July 30, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE OF STERILIZATION VALIDATION METHODS FOR THE AFFINITY ANTERIOR CERVICAL CAGE SYSTEM.

    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