BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P900009 · Supplement: S050 · Decision Mar 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Research PMA P900009 in seconds

    The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
    PMA Number
    P900009
    Supplement Number
    S050
    Device Class
    FDA Class 2
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Regulation Number
    890.5870
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 6, 2026
    Date Received
    February 6, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change in the manufacturing facility associated with the transducer cable assembly for the EXOGEN Ultrasound Bone Healing 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