BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P050010 · Supplement: S021 · Decision May 8, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    prodisc L Total Disc Replacement
    PMA Number
    P050010
    Supplement Number
    S021
    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
    May 8, 2020
    Date Received
    July 30, 2019
    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 additional cleaning, passivation and thermal rinse steps, and the following four (4) manufacturing sites, at the following addresses, and for the following purposes:Centinel Spine (Manufacturer)900 Airport Road Suite 3BWest Chester, PA 19380Hammill Medical (Contract Manufacturer)360 Tomahawk DriveMaumee, OH 43537Fruh Verpackungstechnik AG (Contract Manufacturer)Allmendstrasse 47Fehraltoff Switzerland 8320Synergy Health Daniken AG (Contract Sterilizer)Hogenweidstrasse 6Daniken Solothurn Switzerland 4658

    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