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FDA 510(k)

Univers Revers Modular Glenoid System, Half Augment Baseplate

K-Number: K200895 · 2020-08-13

ApplicantArthrex, Inc.
Decision Date2020-08-13
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Univers Revers Modular Glenoid System, Half Augment Baseplate is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-08-13 under approval number K200895. 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, Half Augment Baseplate?

Univers Revers Modular Glenoid System, Half Augment Baseplate is a medical device that received FDA 510(k) clearance on 2020-08-13. It is manufactured by Arthrex, Inc.. The 510(k) number is K200895.

When was Univers Revers Modular Glenoid System, Half Augment Baseplate approved by the FDA?

Univers Revers Modular Glenoid System, Half Augment Baseplate received FDA 510(k) clearance on 2020-08-13, under approval number K200895.

What company makes Univers Revers Modular Glenoid System, Half Augment Baseplate?

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

What is the FDA product code for Univers Revers Modular Glenoid System, Half Augment Baseplate?

The FDA product code for Univers Revers Modular Glenoid System, Half Augment Baseplate is PHX.

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Other Devices by Arthrex, Inc.

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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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