BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Supplement: S033 · Decision Sep 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)
    PMA Number
    P850035
    Supplement Number
    S033
    Device Class
    FDA Class 3
    Product Code
    LOE
    Generic Name
    Stimulator, invasive bone growth
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 18, 2008
    Date Received
    July 22, 2008
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE TRADE NAME WHICH WAS PREVIOUSLY APPROVED AS: SPF-PLUS (60/W) AND SPF- PLUS (60/M). THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) AND IS INDICATED AS A SPINAL FUSING ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOE Stimulator, Invasive Bone Growth