Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EUROPA™ Navigated Instruments

K-Number: K230369 · 2023-06-23

ApplicantMiRus, LLC
Decision Date2023-06-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EUROPA™ Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230369. 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™ Navigated Instruments?

EUROPA™ Navigated Instruments is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is MiRus, LLC. The 510(k) number is K230369.

When did EUROPA™ Navigated Instruments receive FDA 510(k) clearance?

EUROPA™ Navigated Instruments received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230369.

Who is the listed applicant for EUROPA™ Navigated Instruments?

The FDA 510(k) record lists MiRus, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROPA™ Navigated Instruments?

The FDA product code for EUROPA™ Navigated Instruments is OLO.

Other records listing MiRus, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsK252733ATLAS™ Expandable Osteotomy Wedge SystemK242516EUROPA™ Posterior Cervical Fusion SystemK241175MiRus MoRe Lumbar Plating SystemK232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemK232481RIGEL™ 3DR Anterior Cervical Corpectomy System

View all 24 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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.

↑