BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P040006 · Supplement: S004 · Decision Sep 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    IN MOTION ARTIFICIAL DISC
    PMA Number
    P040006
    Supplement Number
    S004
    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
    September 5, 2007
    Date Received
    March 8, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) ADDITIONAL ENDPLATES WITH LARGER FOOTPRINT, LATERAL PLACEMENT OF FIXATION TEETH, AND 1 MM OFFSET ARTICULATING SURFACE; 2) ADDITIONAL CORES WITH MODIFIED OUTER RIM; 3) MODIFIED SURGICAL INSTRUMENTS TO ACCOMMODATE MODIFIED DEVICE COMPONENTS; AND 4) MODIFIED SURGICAL TECHNIQUE.

    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