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FDA 510(k)

Zavation Spinal System

K-Number: K222614 · 2022-12-05

Decision Date2022-12-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation Spinal System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2022-12-05 under approval number K222614. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zavation Spinal System?

Zavation Spinal System is a medical device that received FDA 510(k) clearance on 2022-12-05. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K222614.

When was Zavation Spinal System approved by the FDA?

Zavation Spinal System received FDA 510(k) clearance on 2022-12-05, under approval number K222614.

What company makes Zavation Spinal System?

Zavation Spinal System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Zavation Spinal System?

The FDA product code for Zavation Spinal System is NKB.

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Official Source

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