BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P190030 · Supplement: S004 · Decision May 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    ActaStim-S
    PMA Number
    P190030
    Supplement Number
    S004
    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
    Approved
    Decision Code
    APPR
    Decision Date
    May 13, 2026
    Date Received
    December 30, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for allowance for reconditioning of the ActaStim-S Spine Fusion Stimulator.

    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