BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P910066 · Supplement: S019 · Decision Sep 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
    PMA Number
    P910066
    Supplement Number
    S019
    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
    September 10, 2004
    Date Received
    January 20, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) CHANGE IN THE LABELING TO REFLECT THE NEW COMPANY OWNERSHIP FROM ORTHOLOGIC TO DJ ORTHOPEDICS/ REGENTEK; 2) ADDITION OF A PRODUCT SPECIFICATIONS SECTION TO ALL MANUALS TO COMPLY WITH CANADIAN STANDARDS ASSOCIATION. (APPLIES TO OL SERIES AND SPINALOGIC MANUALS); 3) ADDITION OF REFERENCE SECTION (APPLIES TO SPINALOGIC MANUALS ONLY); AND 4) IN RISK AND BENEFITS SECTION OF THE SPINALOGIC PATIENT MANUAL, REVISION THE STATEMENT "20% GREATER CHANCE OF BACK SURGERY HEALING" TO "THE BENEFIT OF THE SPINALOGIC IS THAT YOU HAVE A GREATER CHANCE OF YOUR BACK SURGERY HEALING IF YOU USE THE DEVICE EVERY DAY THAN IF YOU DON NOT USE IT."

    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