Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay

K-Number: K182039 · 2018-09-28

ApplicantArthrex, Inc.
Decision Date2018-09-28
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K182039. 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 Porous Coated Baseplate and Universal Glenoid Inlay?

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Arthrex, Inc.. The 510(k) number is K182039.

When was Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay approved by the FDA?

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay received FDA 510(k) clearance on 2018-09-28, under approval number K182039.

What company makes Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay?

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay?

The FDA product code for Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay is PHX.

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

View all 168 devices →

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.

↑