FDA 510(k)

FX V135 EASYTECH® Shoulder System

K-Nummer: K254154 · 2026-05-01

AntragstellerFX Shoulder Solutions, Inc.

Entscheidungsdatum2026-05-01

ProduktcodePKC

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

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Verwandte Geräte (Code: PKC)

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