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FDA 510(k)

N22 EZ Glenosphere

K-Number: K252516 · 2026-01-15

ApplicantShoulder Innovations, Inc.
Decision Date2026-01-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

N22 EZ Glenosphere is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2026-01-15 under 510(k) 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. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K252516.

When did N22 EZ Glenosphere receive FDA 510(k) clearance?

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

Who is the listed applicant for N22 EZ Glenosphere?

The FDA 510(k) record lists Shoulder Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N22 EZ Glenosphere?

The FDA product code for N22 EZ Glenosphere is PHX.

Other records listing Shoulder Innovations, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254128InSet Reverse Total Shoulder SystemK252221Inset Reverse Total Shoulder SystemK241817InSet Total Shoulder SystemK213615Shoulder Innovations Total Shoulder SystemK210533Inset Reverse Total Shoulder SystemK192365Shoulder Innovations Total Shoulder System

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Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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