BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P110002 · Supplement: S016 · Decision Mar 3, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    MOBI-C CERVICAL DISC PROSTHESIS.
    PMA Number
    P110002
    Supplement Number
    S016
    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
    March 3, 2017
    Date Received
    November 1, 2016
    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 a manufacturing site located at Millstone Medical Outsourcing, 8836 Polk Lane, Suite 100, Olive Branch Mississippi for kitting and shipping of new components as well as reconditioning and servicing of used instruments from the field for reuse.

    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