BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Supplement: S023 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
    PMA Number
    P850035
    Supplement Number
    S023
    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
    May 1, 1998
    Date Received
    April 9, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a 4cm mesh cathode to be used with the SpF-2T stimulator and a 8cm mesh cathode to be used with the SpF-XL IIb stimulator. The device, as modified, will be marketed under the trade names SpF-2T/CM and SpF-XL IIb 2/DM and is indicated for the same used as the SpF-2T and SpF-XL IIb.

    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