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

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P040001 · Supplement: S003 · Decision Oct 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    X-STOP IPD SYSTEM
    PMA Number
    P040001
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NQO
    Generic Name
    Prosthesis, spinous process spacer/plate
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 19, 2006
    Date Received
    September 19, 2006
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES IN PACKAGING FOOTPRINT, PACKAGING PROCESSES, LABELING PROCESSES AND MANUFACTURING FLOW FOR THE DEVICE.

    Classifications

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

    Product Code Device Name
    NQO Prosthesis, Spinous Process Spacer/Plate