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

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P110008 · Supplement: S004 · Decision Feb 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    coflex Interlaminar Technology
    PMA Number
    P110008
    Supplement Number
    S004
    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
    February 9, 2016
    Date Received
    January 14, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a second supplier for the instruments with the following part numbers: UAT00008, UAT00010, UAT00012, UAT00014, UAT00016, UBT10008, UBT10010, UBT10012, UBT10014, UBT10016, UAT10100, UAT10200, UAT10300, UAT20100, and UAT20110.

    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