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FDA 510(k)

Arthrex Univers Revers CA Heads and Adapters

K-Number: K151527 · 2016-04-19

ApplicantArthrex, Inc.
Decision Date2016-04-19
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers CA Heads and Adapters is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2016-04-19 under approval number K151527. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Univers Revers CA Heads and Adapters?

Arthrex Univers Revers CA Heads and Adapters is a medical device that received FDA 510(k) clearance on 2016-04-19. It is manufactured by Arthrex, Inc.. The 510(k) number is K151527.

When was Arthrex Univers Revers CA Heads and Adapters approved by the FDA?

Arthrex Univers Revers CA Heads and Adapters received FDA 510(k) clearance on 2016-04-19, under approval number K151527.

What company makes Arthrex Univers Revers CA Heads and Adapters?

Arthrex Univers Revers CA Heads and Adapters is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers Revers CA Heads and Adapters?

The FDA product code for Arthrex Univers Revers CA Heads and Adapters is HSD.

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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.