BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Supplement: S022 · Decision Apr 22, 1997
    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
    S022
    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 22, 1997
    Date Received
    April 8, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR WHICH IS A MODIFICATION OF THE SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR. THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR HAS A SMALLER GENERATOR CASE THAN THE SPF-XL II IMPLANTALBLE SPINAL FUSION STIMULATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR AND IS INDICATED FOR USE AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 3 OR MORE LEVELS.

    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