BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Spinous Process Spacer/Plate

    PMA: P040001 · Supplement: S008 · Decision Dec 14, 2007
    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 PROCESS DECOMPRESSION SYSTEM
    PMA Number
    P040001
    Supplement Number
    S008
    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
    December 14, 2007
    Date Received
    October 26, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT KYPHON, INC., SUNNYVALE, CALIFORNIA, FOR INSPECTION, PACKAGING AND FINAL ACCEPTANCE.

    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