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FDA 510(k)

Vital Navigation System

K-Number: K213720 · 2022-01-07

ApplicantZimvie (Zimmer Biomet Spine, Inc.)
Decision Date2022-01-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Vital Navigation System is a medical device manufactured by Zimvie (Zimmer Biomet Spine, Inc.). It received FDA 510(k) clearance on 2022-01-07 under approval number K213720. 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 Vital Navigation System?

Vital Navigation System is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Zimvie (Zimmer Biomet Spine, Inc.). The 510(k) number is K213720.

When was Vital Navigation System approved by the FDA?

Vital Navigation System received FDA 510(k) clearance on 2022-01-07, under approval number K213720.

What company makes Vital Navigation System?

Vital Navigation System is manufactured by Zimvie (Zimmer Biomet Spine, Inc.).

What is the FDA product code for Vital Navigation System?

The FDA product code for Vital Navigation System is OLO.

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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) PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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