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FDA 510(k)

Easytech® Anatomical Shoulder System

K-Number: K201391 · 2021-02-16

ApplicantFx Shoulder USA, Inc.
Decision Date2021-02-16
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Easytech® Anatomical Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K201391. 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 Easytech® Anatomical Shoulder System?

Easytech® Anatomical Shoulder System is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K201391.

When did Easytech® Anatomical Shoulder System receive FDA 510(k) clearance?

Easytech® Anatomical Shoulder System received FDA 510(k) clearance on 2021-02-16, under 510(k) number K201391.

Who is the listed applicant for Easytech® Anatomical Shoulder System?

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

What is the FDA product code for Easytech® Anatomical Shoulder System?

The FDA product code for Easytech® Anatomical Shoulder System is PKC.

Other records listing Fx Shoulder USA, 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.

K240278Full Wedge Lateralized and Augmented BaseplatesK223801FX V135(TM) Shoulder ProsthesisK222936Humeris® 135 Shoulder SystemK213117FX V135 Shoulder ProsthesisK210790Lateralized and Augmented BaseplatesK191698TiN Coated Humeral Head

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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.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.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.

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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