BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P030034 · Decision Dec 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM
    PMA Number
    P030034
    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 23, 2004
    Date Received
    August 22, 2003
    Expedited Review
    N
    Docket Number
    05M-0028

    Advisory Committee Statement

    APPROVAL FOR THE CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM. THE CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM IS A NON-INVASIVE, PULSED ELECTROMAGNETIC BONE GROWTH STIMULATOR INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSION.

    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