BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Reherniation Reduction Device

    PMA: P160050 · Supplement: S010 · Decision Oct 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Reherniation Reduction Device
    Trade Name
    Barricaid® Annular Closure Device
    PMA Number
    P160050
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    QES
    Generic Name
    Reherniation reduction device
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 9, 2025
    Date Received
    February 3, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a new 6mm baseplate sized implant.

    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