BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P070001 · Supplement: S026 · Decision Mar 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    prodisc - C and prodisc - C Nova (Indicated for Single Level Use)
    PMA Number
    P070001
    Supplement Number
    S026
    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 1, 2024
    Date Received
    February 6, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modification to the device labeling to include the addition of the following precaution statement: “Precaution: The safety and effectiveness of the prodisc C, when implanted at more than one cervical spinal level and/or adjacent to an anterior cervical discectomy and fusion (ACDF) has not been established.”

    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