BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P060023 · Decision May 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    BRYAN CERVICAL DISC PROSTHESIS
    PMA Number
    P060023
    Device Class
    FDA Class 3
    Product Code
    MJO
    Generic Name
    Prosthesis, intervertebral disc
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 12, 2009
    Date Received
    June 29, 2006
    Expedited Review
    N
    Docket Number
    09M-0243

    Advisory Committee Statement

    APPROVAL FOR THE BRYAN CERVICAL DISC. THE DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY AND/OR MYELOPATHY.THE BRYAN DEVICE IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. INTRACTABLE RADICULOPATHYAND/OR MYELOPATHY IS DEFINED AS ANY COMBINATION OF THE FOLLOWING: DISC HERNIATION WITHRADICULOPATHY. SPONDYLOTIC RADICULOPATHY, DISC HERNIATION WITH MYELOPATHY, OR SPONDYLOTICMYELOPATHY RESULTING IN IMPAIRED FUNCTION AND AT LEAST ONE CLINICAL NEUROLOGICAL SIGN ASSOCIATEDWITH THE CERVICAL LEVEL TO BE TREATED, AND NECESSITATING SURGERY AS DEMONSTRATED USING COMPUTEDTOMOGRAPHY (CT), MYELOGRAPHY AND CT, AND/OR MAGNETIC RESONANCE IMAGING (MR1). PATIENTSRECEIVING THE BRYAN CERVICAL DISC SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE BRYAN CERVICAL DISC.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MJO Prosthesis, Intervertebral Disc