BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P910066 · Supplement: S023 · Decision Jun 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
    PMA Number
    P910066
    Supplement Number
    S023
    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
    June 28, 2007
    Date Received
    February 5, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE CONTROL BOX FOR THE OL1000, OL1000 SINGLE COIL (SIZE 2/3/4), AND SPINALOGIC DEVICES INCLUDING ENLARGED LCD ICON GRAPHICS AND PROMPTS, 9 VOLT ALKALINE BATTERY POWER SOURCE, AND UPDATED DEVICE SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS. THE OL1000 AND OL1000 SC DEVICES ARE INTENDED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES. THE SPINALOGIC DEVICE IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.

    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