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FDA 510(k)

FX V135 EASYTECH® Shoulder System

K-Number: K254154 · 2026-05-01

ApplicantFX Shoulder Solutions, Inc.
Decision Date2026-05-01
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FX V135 EASYTECH® Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is FX Shoulder Solutions, Inc.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K254154. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FX V135 EASYTECH® Shoulder System?

FX V135 EASYTECH® Shoulder System is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is FX Shoulder Solutions, Inc.. The 510(k) number is K254154.

When did FX V135 EASYTECH® Shoulder System receive FDA 510(k) clearance?

FX V135 EASYTECH® Shoulder System received FDA 510(k) clearance on 2026-05-01, under 510(k) number K254154.

Who is the listed applicant for FX V135 EASYTECH® Shoulder System?

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

What is the FDA product code for FX V135 EASYTECH® Shoulder System?

The FDA product code for FX V135 EASYTECH® Shoulder System is PKC.

Related Devices (Code: PKC)

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.

K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.K220418Tornier Perform Humeral System – StemlessTornier, 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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