FDA 510(k)

EUROPA Posterior Cervical Fusion Navigated Instruments

K-Number: K253444 · 2026-03-18

Decision Date2026-03-18

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EUROPA Posterior Cervical Fusion Navigated Instruments is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2026-03-18 under approval number K253444. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROPA Posterior Cervical Fusion Navigated Instruments?

EUROPA Posterior Cervical Fusion Navigated Instruments is a medical device that received FDA 510(k) clearance on 2026-03-18. It is manufactured by MiRus, LLC. The 510(k) number is K253444.

When was EUROPA Posterior Cervical Fusion Navigated Instruments approved by the FDA?

EUROPA Posterior Cervical Fusion Navigated Instruments received FDA 510(k) clearance on 2026-03-18, under approval number K253444.

What company makes EUROPA Posterior Cervical Fusion Navigated Instruments?

EUROPA Posterior Cervical Fusion Navigated Instruments is manufactured by MiRus, LLC.

What is the FDA product code for EUROPA Posterior Cervical Fusion Navigated Instruments?

The FDA product code for EUROPA Posterior Cervical Fusion Navigated Instruments is OLO.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.