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

    Intervertebral Fusion Device With Bone Graft, Lumbar

    PMA: P000028 · Decision Jun 13, 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
    AFFINITY (TM) CAGE SYSTEM
    PMA Number
    P000028
    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
    June 13, 2002
    Date Received
    July 11, 2000
    Expedited Review
    Y
    Docket Number
    03M-0532

    Advisory Committee Statement

    APPROVAL FOR THE AFFINITY CAGE SYSTEM. THIS DEVICE IS INDICATED FOR ANTERIOR CERVICAL INTERBODY FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH CERVICAL DISC DISEASE AT ONE LEVEL FROM THE C2-C3 DISC TO THE C7-T1 DISC. CERVICAL DISC DISEASE IS DEFINED AS INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY WITH HERNIATED DISC AND/OR OSTEOPHYTE FORMATION ON POSTERIOR VERTEBRAL ENDPLATES PRODUCING SYMPTOMATIC NERVE ROOT AND/OR SPINAL CORD COMPRESSION CONFIRMED BY RADIOGRAPHIC STUDIES. AFFINITY IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND 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