BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P790002 · Supplement: S023 · Decision Sep 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    EBI BONE HEALING SYSTEM
    PMA Number
    P790002
    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
    September 26, 2005
    Date Received
    June 17, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THREE NEW COILS: THE FLX 5, THE XL COILETTE AND THE MINI COILETTE AND A MODIFIED VERSION OF THE BONE HEALING SYSTEM MODEL 2001 CONTROLLER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI BONE HEALING SYSTEM AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSES IN THE APPENDICULAR SYSTEM.

    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