BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P790002 · Supplement: S018 · Decision Jun 11, 1997
    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(R)
    PMA Number
    P790002
    Supplement Number
    S018
    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 11, 1997
    Date Received
    February 10, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FLX(R) COILETTE WHICH WILL BE USED TO DELIVERY THE APPROVED REPETITIVE PULSE BURST SIGNAL PRODUCED BY THE EBI BONE HEALING SYSTEM MODEL 1200. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI FLX COILETTE TO BE USED WITH THE EBI BONE HEALING SYSTEM MODEL 1200 WHICH IS INDICATED FOR NONUNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDARTHROSES.

    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