BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P790005 · Supplement: S039 · Decision Jul 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR
    PMA Number
    P790005
    Supplement Number
    S039
    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
    July 17, 1997
    Date Received
    October 17, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Model ST-72 Implant Tester for use with the SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R)-2T, SpF(R)-4T, SpF(R)-XL, and the SpF(R)-XL II) and the OsteoGen(TM) Implantable Spinal Fusion Stimulator product line.

    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