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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 the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2026-02-03 under 510(k) 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. The listed applicant is Ulrich Medical USA, Inc.. The 510(k) number is K252087.

When did Navigation Module of the Cortium® System receive FDA 510(k) clearance?

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

Who is the listed applicant for Navigation Module of the Cortium® System?

The FDA 510(k) record lists Ulrich Medical USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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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