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FDA 510(k)

Navigation Module of the Cortium® System

K-Number: K252087 · 2026-02-03

ApplicantUlrich Medical USA, Inc.
Decision Date2026-02-03
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigation Module of the Cortium® System is a medical device manufactured by Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2026-02-03 under approval number K252087. 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 Navigation Module of the Cortium® System?

Navigation Module of the Cortium® System is a medical device that received FDA 510(k) clearance on 2026-02-03. It is manufactured by Ulrich Medical USA, Inc.. The 510(k) number is K252087.

When was Navigation Module of the Cortium® System approved by the FDA?

Navigation Module of the Cortium® System received FDA 510(k) clearance on 2026-02-03, under approval number K252087.

What company makes Navigation Module of the Cortium® System?

Navigation Module of the Cortium® System is manufactured by Ulrich Medical USA, Inc..

What is the FDA product code for Navigation Module of the Cortium® System?

The FDA product code for Navigation Module of the Cortium® System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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.

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