FDA 510(k)

N22 EZ Glenosphere

K-Number: K252516 · 2026-01-15

Decision Date2026-01-15

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

N22 EZ Glenosphere is a medical device manufactured by Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2026-01-15 under approval number K252516. 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 N22 EZ Glenosphere?

N22 EZ Glenosphere is a medical device that received FDA 510(k) clearance on 2026-01-15. It is manufactured by Shoulder Innovations, Inc.. The 510(k) number is K252516.

When was N22 EZ Glenosphere approved by the FDA?

N22 EZ Glenosphere received FDA 510(k) clearance on 2026-01-15, under approval number K252516.

What company makes N22 EZ Glenosphere?

N22 EZ Glenosphere is manufactured by Shoulder Innovations, Inc..

What is the FDA product code for N22 EZ Glenosphere?

The FDA product code for N22 EZ Glenosphere is PHX.

Other Devices by Shoulder Innovations, Inc.

K173824Humeral Short Stem System K192365Shoulder Innovations Total Shoulder System K210533Inset Reverse Total Shoulder System K213615Shoulder Innovations Total Shoulder System K252221Inset Reverse Total Shoulder System K241817InSet Total Shoulder System

View all 8 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.