BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P170036 · Supplement: S008 · Decision Aug 6, 2021
    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
    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
    August 6, 2021
    Date Received
    December 22, 2020
    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 Infinity Labs SD located at 1836 Stone Avenue, San Jose, California, 95125, for ethylene oxide sterilization of the M6-C Artificial Cervical Disc system.

    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