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510(k) Data Aggregation

    K Number
    K202552
    Device Name
    Midas Rex Attachments and Dissecting Tools
    Manufacturer
    Medtronic Powered Surgical Solutions (MPSS)
    Date Cleared
    2020-11-02

    (60 days)

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

    Medtronic Powered Surgical Solutions (MPSS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midas Rex™ attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures. Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
    Device Description
    Midas Rex™ attachments and surgical dissecting tools for Mazor are intended for the incision/cutting, drilling, burring, and removal of hard tissue and bone. The subject instruments are designed to be utilized through a cannula, for use with the Mazor X Stealth Edition™ system in open and minimally invasive spine procedures. The subject devices perform the intended function as part of the existing Medtronic Midas Rex TM surgical drill systems which consist of the subject attachments and dissecting tools, electric and pneumatic drill handpieces and system accessories.
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