BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P090029 · Supplement: S015 · Decision Dec 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    PRESTIGE LP Cervical Disc
    PMA Number
    P090029
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    MJO
    Generic Name
    Prosthesis, intervertebral disc
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 1, 2020
    Date Received
    October 21, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to replace the current deionized water system to a new reverse osmosis & deionized water system with new piping and fixtures. This change applies to the water system is being replaced by a new reverse osmosis & deionized water system with new piping and fixtures. The following manufacturing facility is affected by the change(s): Orchid Orthopedics Solutions, 23149 Commerce Drive, Farmington Hills, MI 48335 USA.

    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