FDA 510(k)

EUROPA Pedicle Screw System

K-Number: K182970 · 2019-01-22

Decision Date2019-01-22

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EUROPA Pedicle Screw System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2019-01-22 under approval number K182970. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROPA Pedicle Screw System?

EUROPA Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-01-22. It is manufactured by MiRus, LLC. The 510(k) number is K182970.

When was EUROPA Pedicle Screw System approved by the FDA?

EUROPA Pedicle Screw System received FDA 510(k) clearance on 2019-01-22, under approval number K182970.

What company makes EUROPA Pedicle Screw System?

EUROPA Pedicle Screw System is manufactured by MiRus, LLC.

What is the FDA product code for EUROPA Pedicle Screw System?

The FDA product code for EUROPA Pedicle Screw System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by MiRus, LLC

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Related Devices (Code: NKB)

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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.