BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Reherniation Reduction Device

    PMA: P160050 · Supplement: S009 · Decision Jul 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Reherniation Reduction Device
    Trade Name
    Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb
    PMA Number
    P160050
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    QES
    Generic Name
    Reherniation reduction device
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 3, 2024
    Date Received
    June 5, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a site change for the approved supplier that manufactures and assembles sub-components to the pusher instrument and an addition of a secondary supplier to the final passivation step of the bone anchor component of the final implant device

    Classifications

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

    Product Code Device Name
    QES Reherniation Reduction Device