BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P950002 · Supplement: S013 · Decision Jan 29, 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
    VISTA LORDOTIC INTERBODY FUSION CAGE
    PMA Number
    P950002
    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
    January 29, 2004
    Date Received
    December 24, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE VISTA LORDOTIC DEVICE TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VISTA LORDOTIC AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO CONTINUOUS LEVELS FROM L4-L5 AND/OR L5-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL(S). 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. VISTA LORDOTIC DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH.

    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