BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P090029 · Supplement: S008 · Decision Jan 31, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    PRESTIGE: LP(TM) CERVICAL DISC
    PMA Number
    P090029
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    MJO
    Generic Name
    Prosthesis, intervertebral disc
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 31, 2018
    Date Received
    July 13, 2017
    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 manufacturing sites located at MedTorque, Inc., 612 W. Lamont Road, Elmhurst, Illinois, for instrument machining and laser marking of the BRYAN™ and PRESTIGE LP instruments, and at Medtronic Sofamor Danek USA, Inc., 4340 Swinnea Road, Memphis, Tennessee, for the manufacturing of PRESTIGE LP Streamlined Instrument.

    Classifications

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

    Product Code Device Name
    MJO Prosthesis, Intervertebral Disc