BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P170036 · Supplement: S015 · Decision Jul 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    M6-C Artificial Cervical Disc
    PMA Number
    P170036
    Supplement Number
    S015
    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
    July 10, 2024
    Date Received
    June 10, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updated labeling to communicate storage temperature limitations on external packaging and instructions for use

    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