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FDA 510(k)

Arthrex Univers Revers Modular Glenoid System

K-Number: K191960 · 2019-12-23

ApplicantArthrex, Inc.
Decision Date2019-12-23
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers Modular Glenoid System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-12-23 under approval number K191960. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Univers Revers Modular Glenoid System?

Arthrex Univers Revers Modular Glenoid System is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by Arthrex, Inc.. The 510(k) number is K191960.

When was Arthrex Univers Revers Modular Glenoid System approved by the FDA?

Arthrex Univers Revers Modular Glenoid System received FDA 510(k) clearance on 2019-12-23, under approval number K191960.

What company makes Arthrex Univers Revers Modular Glenoid System?

Arthrex Univers Revers Modular Glenoid System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers Revers Modular Glenoid System?

The FDA product code for Arthrex Univers Revers Modular Glenoid System is PHX.

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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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