BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P910066 · Supplement: S008 · Decision Jun 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
    PMA Number
    P910066
    Supplement Number
    S008
    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 12, 1998
    Date Received
    December 30, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the indications for use language to state "The Orthologic 1000 Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site show no visibly progressive sign s of healing"; and "The Orthologic CC Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauam, ecxluding vertebrae and all flate bones. A nonunion is considred to be established when the fracture site shows no visibly progressive signs of healing."

    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