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FDA 510(k)

Vy Spine™ VyWasher™ Buttress System

K-Number: K213219 · 2021-12-23

ApplicantVy Spine, LLC
Decision Date2021-12-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vy Spine™ VyWasher™ Buttress System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2021-12-23 under approval number K213219. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vy Spine™ VyWasher™ Buttress System?

Vy Spine™ VyWasher™ Buttress System is a medical device that received FDA 510(k) clearance on 2021-12-23. It is manufactured by Vy Spine, LLC. The 510(k) number is K213219.

When was Vy Spine™ VyWasher™ Buttress System approved by the FDA?

Vy Spine™ VyWasher™ Buttress System received FDA 510(k) clearance on 2021-12-23, under approval number K213219.

What company makes Vy Spine™ VyWasher™ Buttress System?

Vy Spine™ VyWasher™ Buttress System is manufactured by Vy Spine, LLC.

What is the FDA product code for Vy Spine™ VyWasher™ Buttress System?

The FDA product code for Vy Spine™ VyWasher™ Buttress System is KWQ.

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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.