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

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P980048 · Decision Apr 20, 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/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
    PMA Number
    P980048
    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
    April 20, 2001
    Date Received
    December 15, 1998
    Expedited Review
    Y
    Docket Number
    03M-0122

    Advisory Committee Statement

    APPROVAL FOR THE BAK/CERVICAL (BAK/C(R)) INTERBODY FUSION SYSTEM. THE DEVICE IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) OF THE CERVICAL SPINE WITH ACCOMPANYING RADICULAR SYMPTOMS AT ONE DISC LEVEL. DDD IS DEFINED AS DISCOGENIC PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. BAK/C IMPLANTS ARE USED TO FACILITATE FUSION IN THE CERVICAL SPINE AND ARE PLACED VIA AN ANTERIOR APPROACH AT THE C-3 TO C-7 DISC LEVELS USING AUTOGRAFT BONE.

    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