Manufacturer
MiRus, LLCEUROPA™ Navigated Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K230369
- Device name
- EUROPA™ 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
- 2023-02-10
- Decision date
- 2023-06-23
- 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™ 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.
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.
Summary parsed at:2026-06-19 05:44:28 UTC