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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 a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2021-02-16 under approval 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. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K201391.

When was Easytech® Anatomical Shoulder System approved by the FDA?

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

What company makes Easytech® Anatomical Shoulder System?

Easytech® Anatomical Shoulder System is manufactured by Fx Shoulder USA, Inc..

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

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

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Fx Shoulder USA, Inc.

K19220632mm Glenosphere and Humeral Cup K191698TiN Coated Humeral Head K191146Humelock TiN Coated Glenosphere K193394Humeral Cup Stability & Humeral Cup 135/145o Stability K192799Glenoid Baseplate with Screw K210790Lateralized and Augmented Baseplates

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.

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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