BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P950002 · Supplement: S002 · Decision May 9, 1997
    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
    Supplement Number
    S002
    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 9, 1997
    Date Received
    February 5, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE ADDITION OF THE FOLLOWING SIZES TO THE BAK PRODUCT LINE: A) BAK IMPLANTS (MINOR DIAMETER (MM) X LENGTH (MM)) 11X20, 11X24, 11X28, 11X32, 11X36; 13X24, 13X28, 13X32, 13X36, 13X40; 15X28, 15X32, 15X36, 15X40, 15X44; 17X20, 17X32, 17X36, 17X40, 17X44; 19X24, 19X28, 19X32, 19X36, 19X40, 19X44; 21X28, 21X32, 21X36, 21X40, 21X44; AND (B) END CAPS (DIAMETER (MM)) 11; 19; AND 21.

    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