DeviceClearance

EUROPA Posterior Cervical Fusion Navigated Instruments— 510(k) K253444

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K253444 for EUROPA Posterior Cervical Fusion Navigated Instruments, Substantially Equivalent on 2026-03-18. Applicant: MiRus, LLC. Device class: 2.

Summary

MiRus' EUROPA Posterior Cervical Fusion Navigated Instruments are filed under OLO, orthopedic stereotaxic instruments. The record doesn't list the individual instruments.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.

MiRus filed from Marietta, Georgia. Review took 167 calendar days (October 2, 2025 to March 18, 2026).

Clearance details

Applicant
MiRus, LLC
Product code
Product code OLO
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marietta, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OLO

product code OLO
Death
11
Injury
2,799
Malfunction
11,105
Other
1
Total
13,916

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.