BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850007 · Supplement: S024 · Decision Nov 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM
    PMA Number
    P850007
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 3, 1998
    Date Received
    September 22, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval t use a smaller gauge wire for the Transducer Coil, change from PVC to Neoprene for the inside and outside covers of both front and rear transducer coils, and slightly reduce the thickness of the Kydex material. The device will be marketed under the trade name Spinal-Stim(R) and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.

    Classifications

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

    Product Code Device Name
    LOF Stimulator, Bone Growth, Non-Invasive