BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P950002 · Supplement: S007 · Decision May 1, 2002
    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, BP/LORDOTIC DEVICE
    PMA Number
    P950002
    Supplement Number
    S007
    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
    May 1, 2002
    Date Received
    February 11, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD THE BP/LORDOTIC TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BP/LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L4-L5 AND/OR L5-S1 LEVELS. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). BP/LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR LAPAROSCOPIC APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.

    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