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510(k) Data Aggregation

    K Number
    K230369
    Device Name
    EUROPA™ Navigated Instruments
    Manufacturer
    Date Cleared
    2023-06-23

    (133 days)

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

    MiRus LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EUROPA™ Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
    Device Description
    The EUROPA™ Navigated Instruments is intended to be used with the EUROPA™ Pedicle Screw System. The EUROPA™ Navigated Instruments are non-sterile, re-usable instruments including probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation ® System and are manufactured from Stainless Steel per ASTM F899.
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