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FDA 510(k)

Univers Revers CA Head and Adapter

K-Number: K233260 · 2024-02-12

ApplicantArthrex, Inc.
Decision Date2024-02-12
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Univers Revers CA Head and Adapter is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2024-02-12 under approval number K233260. 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 CA Head and Adapter?

Univers Revers CA Head and Adapter is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Arthrex, Inc.. The 510(k) number is K233260.

When was Univers Revers CA Head and Adapter approved by the FDA?

Univers Revers CA Head and Adapter received FDA 510(k) clearance on 2024-02-12, under approval number K233260.

What company makes Univers Revers CA Head and Adapter?

Univers Revers CA Head and Adapter is manufactured by Arthrex, Inc..

What is the FDA product code for Univers Revers CA Head and Adapter?

The FDA product code for Univers Revers CA Head and Adapter is HSD.

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Related Devices (Code: HSD)

K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH K151527Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc. K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC

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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