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FDA 510(k)

Arthrex Univers Revers Shoulder Prosthesis System

K-Number: K161782 · 2016-11-21

ApplicantArthrex, Inc.
Decision Date2016-11-21
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers Shoulder Prosthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K161782. 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 Shoulder Prosthesis System?

Arthrex Univers Revers Shoulder Prosthesis System is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Arthrex, Inc.. The 510(k) number is K161782.

When did Arthrex Univers Revers Shoulder Prosthesis System receive FDA 510(k) clearance?

Arthrex Univers Revers Shoulder Prosthesis System received FDA 510(k) clearance on 2016-11-21, under 510(k) number K161782.

Who is the listed applicant for Arthrex Univers Revers Shoulder Prosthesis System?

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 Arthrex Univers Revers Shoulder Prosthesis System?

The FDA product code for Arthrex Univers Revers Shoulder Prosthesis System is HSD.

Other records listing Arthrex, Inc. as applicant

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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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, 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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