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

    Prosthesis, Intervertebral Disc

    PMA: P110009 · Supplement: S038 · Decision Mar 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    Mobi-C® P&F Cervical Disc Prosthesis
    PMA Number
    P110009
    Supplement Number
    S038
    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
    March 23, 2026
    Date Received
    March 9, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    addition of a new raw material supplier (IKH) for titanium powder used in the plasma spray coating of Mobi-C® inferior and superior endplates, and qualification of a back-up final cleaning line (HAMO 210 #LA2165) for cleaning of Mobi-C® inserts and jaws performed at the same Viant facility

    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