BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P910066 · Supplement: S004 · Decision Jun 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    ORTHOLOGIC 1000 BONE GROWTH STIMULATOR
    PMA Number
    P910066
    Supplement Number
    S004
    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 25, 1997
    Date Received
    April 5, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ORTHOLOGIC 1000 SINGLE CLOSED COIL SOFT PACK BONE GROWTH STIMULATOR IN SIZES XS, S, M, L, AND XL AND FOR THE ORTHOLOGIC 1000 BONE GROWTH STIMULATOR IN THE MEDIUM SIZE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES OL 1000-CC AND OL 1000 (MEDIUM) AND ARE INDICATED FOR THE NONINVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VETEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED.

    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