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FDA 510(k)

Innovasis Navigation Instruments

K-Number: K250182 · 2025-03-24

ApplicantInnovasis, Inc.
Decision Date2025-03-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Innovasis Navigation Instruments is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2025-03-24 under approval number K250182. 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 Innovasis Navigation Instruments?

Innovasis Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by Innovasis, Inc.. The 510(k) number is K250182.

When was Innovasis Navigation Instruments approved by the FDA?

Innovasis Navigation Instruments received FDA 510(k) clearance on 2025-03-24, under approval number K250182.

What company makes Innovasis Navigation Instruments?

Innovasis Navigation Instruments is manufactured by Innovasis, Inc..

What is the FDA product code for Innovasis Navigation Instruments?

The FDA product code for Innovasis Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

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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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