BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Spinal Pedicle Screw, Fixation, Appliance System

    PMA: P960025 · Supplement: S005 · Decision Sep 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Spinal Pedicle Screw, Fixation, Appliance System
    Trade Name
    LUMBAR I/F CAGE WITH VSP SPINE SYSTEM
    PMA Number
    P960025
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MCV
    Generic Name
    SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 8, 2000
    Date Received
    June 6, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE MATERIAL OF THE I/F CAGE DEVICE COMPONENT FROM INJECTION MOLDED PEKEKK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70 TO INJECTION MOLDED PEEK WITH CHOPPED CARBON FIBERS IN A FIBER:MATRIX RATIO OF 30:70.

    Classifications

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

    Product Code Device Name
    MCV Spinal Pedicle Screw, Fixation, Appliance System