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

    Prosthesis, Intervertebral Disc

    PMA: P070001 · Supplement: S021 · Decision Oct 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    prodisc® C
    PMA Number
    P070001
    Supplement Number
    S021
    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
    October 28, 2021
    Date Received
    September 21, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Expand the responsibilities of Hammill Medical (360 Tomahawk Drive Maumee, OH 43537) to perform the following for the prodisc -C modified endplates (-SK, -NOVO, and -VIVO) once the modified endplates are approved: acquire the raw material, machine the endplate components, polish the superior endplates, complete inspections and bead blast the endplates.

    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