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510(k) Data Aggregation

    K Number
    K253444

    Validate with FDA (Live)

    Device Name
    EUROPA™ Posterior Cervical Fusion Navigated Instruments
    Manufacturer
    MiRus, LLC
    Date Cleared
    2026-03-18

    (167 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K140454,K143628
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EUROPA™ Posterior Cervical Fusion Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ Posterior Cervical Fusion 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™ Posterior Cervical Fusion Navigated Instruments are intended to be used with the EUROPA™ Posterior Cervical Fusion System screws. The EUROPA™ Posterior Cervical Fusion Navigated Instruments consist of non-sterile, re-usable instruments including probes, drivers, awls, drills, and taps 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.

    AI/ML Overview

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