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FDA 510(k)

Artus™ cervical plate system

K-Number: K202227 · 2020-09-14

Decision Date2020-09-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Artus™ cervical plate system is a medical device manufactured by Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2020-09-14 under approval number K202227. 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 Artus™ cervical plate system?

Artus™ cervical plate system is a medical device that received FDA 510(k) clearance on 2020-09-14. It is manufactured by Ulrich GmbH & Co. KG. The 510(k) number is K202227.

When was Artus™ cervical plate system approved by the FDA?

Artus™ cervical plate system received FDA 510(k) clearance on 2020-09-14, under approval number K202227.

What company makes Artus™ cervical plate system?

Artus™ cervical plate system is manufactured by Ulrich GmbH & Co. KG.

What is the FDA product code for Artus™ cervical plate system?

The FDA product code for Artus™ cervical plate system is KWQ.

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Official Source

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