BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P040001 · Supplement: S016 · Decision Apr 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Prosthesis, Spinous Process Spacer/Plate
    Trade Name
    X-STOP INTERSPINOUS SPACER SYSTEM
    PMA Number
    P040001
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    NQO
    Generic Name
    Prosthesis, spinous process spacer/plate
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 30, 2010
    Date Received
    November 5, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL SURGICAL INSTRUMENTS, CHANGES TO EXISTING INSTRUMENTS AND A NEW STERILIZATION TRAY. THESE NEW COMPONENTS INCLUDE THE SIZING DISTRACTOR, THE SPACER INSERTION INSTRUMENT WITH TRI-LOBE CONNECTORS, THE BI-DIRECTIONAL SIZING DISTRACTOR, THE HORIZONTAL HANDLE, THE TRIAL SPACERS, AND THE TWO-LEVEL STERILIZATION TRAY.

    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