BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P910066 · Supplement: S015 · Decision Aug 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    SPINALOGIC BONE GROWTH STIMULATOR
    PMA Number
    P910066
    Supplement Number
    S015
    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
    August 23, 2000
    Date Received
    March 31, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO *REMOVE THE FOLLOWING PRECAUTION FROM THE SUMMARY OF SAFETY AND EFFECTIVENESS AND PROFESSIONAL LABELING; "THE SAFETY AND EFFECTIVENESS OF THE SPINALOGIC(R) HAS ONLY BEEN STUDIED IN PATIENTS HAVING SPINAL FUSION TREATMENT. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE IN PATIENTS RECEIVING INSTRUMENTATION, WHICH MAY DISTORT THE MAGNETIC FIELD GENERATED BY THE DEVICE AND THUS PRODUCE A LESS EFFECTIVE TREATMENT, HAS NOT BEEN ESTABLISHED"; AND *MODIFY THE FOLLOWING STATEMENT I NTHE RISKS AND BENEFITS SECTION OF THE PATIENT LABELING FROM: "THE SAFETY AND BENEFIT OF THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY," TO "THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY."

    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