BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Decision Apr 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
    PMA Number
    P850035
    Device Class
    FDA Class 3
    Product Code
    LOE
    Generic Name
    Stimulator, invasive bone growth
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 30, 1987
    Date Received
    May 31, 1985
    Expedited Review
    N
    Docket Number
    87M-0174

    Classifications

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

    Product Code Device Name
    LOE Stimulator, Invasive Bone Growth