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FDA 510(k)

Zavation Navigation Instrument System

K-Number: K223808 · 2023-07-12

ApplicantZavation Medical Products, LLC
Decision Date2023-07-12
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zavation Navigation Instrument System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2023-07-12 under approval number K223808. 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 Zavation Navigation Instrument System?

Zavation Navigation Instrument System is a medical device that received FDA 510(k) clearance on 2023-07-12. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K223808.

When was Zavation Navigation Instrument System approved by the FDA?

Zavation Navigation Instrument System received FDA 510(k) clearance on 2023-07-12, under approval number K223808.

What company makes Zavation Navigation Instrument System?

Zavation Navigation Instrument System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Zavation Navigation Instrument System?

The FDA product code for Zavation Navigation Instrument System is OLO.

Related Clinical Trials

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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)

Other Devices by Zavation Medical Products, LLC

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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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