EUROPA™ Posterior Cervical Fusion Navigated Instruments

MiRus, LLC

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

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Company

MiRus, LLC

United States (US)

Product code

OLO

21 CFR 882.4560

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Cited in this 510(k)

Cited as predicate

Device details

FDA 510(k) registration fields

K number: K253444
Device name: EUROPA™ Posterior Cervical Fusion Navigated Instruments
Company: MiRus, LLC
Country / Region: United States(US)
Product code: OLO
Device class: Class 2
Regulation number: 21 CFR 882.4560
Date received: 2025-10-02
Decision date: 2026-03-18
Submission type: Traditional
Technology type: Stereotactic Surgery(AI inferred)
Clinical applications: Spine SurgeryNavigation System
Primary application: Spine Surgery
Classification source: AI classified

Indications for Use

The EUROPA™ Posterior Cervical Fusion Navigated Instruments are intended to be used in the preparation and placement of the EJROPA™ 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.

Intended Use

The EUROPA™ Posterior Cervical Fusion Navigated Instruments are intended to be used in the preparation and placement of the EJROPA™ 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.

Summary parsed at:2026-06-19 04:30:45 UTC

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