BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Supplement: S020 · Decision Aug 20, 1996
    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 MODEL SPF-XL II
    PMA Number
    P850035
    Supplement Number
    S020
    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
    August 20, 1996
    Date Received
    July 19, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR SHICH IS A MODIFICATION OF THE SPF-XL IMPLANTABLE SPINAL FUSION STIMULATOR. THE SPF-XL IMPLANTABLE SPINAL FUSION STIMULATOR CONSISTS OF 4 LEADS, EACH BEING 12 CM IN LENGTH WHILE THE SPF-XL II WILL HAVE ONLY 2 LEADS, EACH BEING 24 CM IN LENGTH. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR

    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