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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2024-02-12 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K233260.

When did Univers Revers CA Head and Adapter receive FDA 510(k) clearance?

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

Who is the listed applicant for Univers Revers CA Head and Adapter?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Arthrex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HSD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH

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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