BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Spinal Pedicle Screw, Fixation, Appliance System

    PMA: P960025 · Supplement: S004 · Decision Jan 12, 2001
    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
    S004
    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
    January 12, 2001
    Date Received
    April 6, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE LUMBAR I/F CAGE COMPONENT OF THE LUMBAR I/F CAGE(R) WITH VSP(R) SPINE SYSTEM WITH ADDITIONAL PEDICLE SCREW SPINAL SYSTEMS. SPECIFICALLY, FOR USE WITH THE FOLLOWING SIX ADDITIONAL POSTERIOR PEDICLE SCREW SPINAL SYSTEMS: 1) THE TI ALLOY VERSION OF THE VSP SPINE SYSTEM; 2) TI ALLOY AND STAINLESS STEEL VERSIONS OF THE ISOLA SPINE SYSTEM; 3) TIMX SPINE SYSTEM; AND 4) THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE MOSS MIAMI SPINE SYSTEM. IN ADDITION, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMBAR I/F CAGE SYSTEM. THE INDICATION FOR THESE IMPLANTS HAS NOT BEEN CHANGED FROM THAT APPROVED ON FEBRUARY 2, 1999.

    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