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FDA 510(k)

Vy Spine™ VySpan™ PCT System

K-Number: K213394 · 2021-12-10

ApplicantVy Spine, LLC
Decision Date2021-12-10
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vy Spine™ VySpan™ PCT System is the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2021-12-10 under 510(k) 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. The listed applicant is Vy Spine, LLC. The 510(k) number is K213394.

When did Vy Spine™ VySpan™ PCT System receive FDA 510(k) clearance?

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

Who is the listed applicant for Vy Spine™ VySpan™ PCT System?

The FDA 510(k) record lists Vy Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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