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510(k) Data Aggregation

    K Number
    K020069
    Device Name
    MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
    Manufacturer
    MEDTRONIC MIDAS REX
    Date Cleared
    2002-03-18

    (68 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC MIDAS REX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
    Device Description
    The Medtronic Midas Rex Legend System is a modular, pneumatic, highspeed instrument system consisting of a motor (handpiece) and accessories/attachments, including but not limited to adapters, spindles, burrs, drills, cutters, and other dissecting tools.
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