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FDA 510(k)

Univers Revers Humeral Cup Implant

K-Number: K221232 · 2022-05-19

ApplicantArthrex, Inc.
Decision Date2022-05-19
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Univers Revers Humeral Cup Implant is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-05-19 under approval number K221232. 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 Univers Revers Humeral Cup Implant?

Univers Revers Humeral Cup Implant is a medical device that received FDA 510(k) clearance on 2022-05-19. It is manufactured by Arthrex, Inc.. The 510(k) number is K221232.

When was Univers Revers Humeral Cup Implant approved by the FDA?

Univers Revers Humeral Cup Implant received FDA 510(k) clearance on 2022-05-19, under approval number K221232.

What company makes Univers Revers Humeral Cup Implant?

Univers Revers Humeral Cup Implant is manufactured by Arthrex, Inc..

What is the FDA product code for Univers Revers Humeral Cup Implant?

The FDA product code for Univers Revers Humeral Cup Implant is HSD.

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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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