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FDA 510(k)

Arthrex Modular Glenoid System-Titanium Glenosphere

K-Number: K212415 · 2021-11-17

ApplicantArthrex, Inc.
Decision Date2021-11-17
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Modular Glenoid System-Titanium Glenosphere is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2021-11-17 under approval number K212415. 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 Modular Glenoid System-Titanium Glenosphere?

Arthrex Modular Glenoid System-Titanium Glenosphere is a medical device that received FDA 510(k) clearance on 2021-11-17. It is manufactured by Arthrex, Inc.. The 510(k) number is K212415.

When was Arthrex Modular Glenoid System-Titanium Glenosphere approved by the FDA?

Arthrex Modular Glenoid System-Titanium Glenosphere received FDA 510(k) clearance on 2021-11-17, under approval number K212415.

What company makes Arthrex Modular Glenoid System-Titanium Glenosphere?

Arthrex Modular Glenoid System-Titanium Glenosphere is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Modular Glenoid System-Titanium Glenosphere?

The FDA product code for Arthrex Modular Glenoid System-Titanium Glenosphere 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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