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FDA 510(k)

Univers Revers Modular Glenoid System, Standard Augment Baseplates

K-Number: K211074 · 2021-09-02

ApplicantArthrex, Inc.
Decision Date2021-09-02
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Univers Revers Modular Glenoid System, Standard Augment Baseplates is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2021-09-02 under approval number K211074. 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 Univers Revers Modular Glenoid System, Standard Augment Baseplates?

Univers Revers Modular Glenoid System, Standard Augment Baseplates is a medical device that received FDA 510(k) clearance on 2021-09-02. It is manufactured by Arthrex, Inc.. The 510(k) number is K211074.

When was Univers Revers Modular Glenoid System, Standard Augment Baseplates approved by the FDA?

Univers Revers Modular Glenoid System, Standard Augment Baseplates received FDA 510(k) clearance on 2021-09-02, under approval number K211074.

What company makes Univers Revers Modular Glenoid System, Standard Augment Baseplates?

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

What is the FDA product code for Univers Revers Modular Glenoid System, Standard Augment Baseplates?

The FDA product code for Univers Revers Modular Glenoid System, Standard Augment Baseplates is PHX.

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Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

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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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