BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850022 · Supplement: S025 · Decision Sep 9, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR
    PMA Number
    P850022
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 9, 2015
    Date Received
    August 10, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    QUALIFY TWO ALTERNATE SUPPLIERS FOR THE SOFT-TOUCH® HYDROGEL DISPOSABLE, CUTANEOUS ELECTRODES AND TO REINSTATE THE SOFT-TOUCH 63B HYDROGEL BASED, DISPOSABLE, CUTANEOUS ELECTRODE USED IN CONJUNCTION WITH THE BIOMET® ORTHOPAK® NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND SPINALPAK® NON-INVASIVE SPINE FUSION STIMULATOR 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