BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850007 · Supplement: S035 · Decision Dec 2, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    Spinal-Stim
    PMA Number
    P850007
    Supplement Number
    S035
    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
    December 2, 2016
    Date Received
    July 5, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new fabric, modifications to the control unit housing, modifications to enlarge the Liquid Crystal Display (LCD), a change from a three-cell lithium-ion battery to a single lithium-ion battery, a change in the Printed Circuit Assembly (PCA), a modification to include a smaller power supply, updates to device firmware, a new iOS mobile application, and minor updates to labeling. The modified devices will be marketed under the trade names Spinal-Stim Model 5212 and Cervical-Stim Model 5505.

    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