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510(k) Data Aggregation

    K Number
    K230716
    Device Name
    Robotic Graft Delivery Instruments
    Manufacturer
    Medtronic Sofamor Danek Inc
    Date Cleared
    2023-07-18

    (125 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medtronic Sofamor Danek Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools. Do not implant instruments.
    Device Description
    The robotic graft delivery instruments are non-sterile re-usable instruments that may be used during the preparation and placement of various graft material during spinal surgery. The subject instruments are made of a medical grade stainless steel commonly used in orthopedic procedures, which meet available national or international standards specifications. The robotic graft delivery instruments are intended to be used when preparing and placing graft material during spinal surgery. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work through the MAZOR X arm guides. The instruments will be provided non-sterile and reusable.
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