FDA 510(k)

Vy Spine VySpan PCT System

K-Number: K213394 · 2021-12-10

Decision Date2021-12-10

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vy Spine VySpan PCT System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2021-12-10 under approval number K213394. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vy Spine VySpan PCT System?

Vy Spine VySpan PCT System is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Vy Spine, LLC. The 510(k) number is K213394.

When was Vy Spine VySpan PCT System approved by the FDA?

Vy Spine VySpan PCT System received FDA 510(k) clearance on 2021-12-10, under approval number K213394.

What company makes Vy Spine VySpan PCT System?

Vy Spine VySpan PCT System is manufactured by Vy Spine, LLC.

What is the FDA product code for Vy Spine VySpan PCT System?

The FDA product code for Vy Spine VySpan PCT System is NKG.

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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.