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FDA 510(k)

Arthrex UNIVERS REVERS COATED BASEPLATE

K-Number: K172371 · 2018-03-22

ApplicantArthrex, Inc.
Decision Date2018-03-22
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex UNIVERS REVERS COATED BASEPLATE is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2018-03-22 under approval number K172371. 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 COATED BASEPLATE?

Arthrex UNIVERS REVERS COATED BASEPLATE is a medical device that received FDA 510(k) clearance on 2018-03-22. It is manufactured by Arthrex, Inc.. The 510(k) number is K172371.

When was Arthrex UNIVERS REVERS COATED BASEPLATE approved by the FDA?

Arthrex UNIVERS REVERS COATED BASEPLATE received FDA 510(k) clearance on 2018-03-22, under approval number K172371.

What company makes Arthrex UNIVERS REVERS COATED BASEPLATE?

Arthrex UNIVERS REVERS COATED BASEPLATE is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex UNIVERS REVERS COATED BASEPLATE?

The FDA product code for Arthrex UNIVERS REVERS COATED BASEPLATE 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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