Easytech® Anatomical Shoulder System

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

FX Shoulder USA, Inc.

The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for Easytech® Anatomical Shoulder System.

Pre-market Notification Details

• Device ID: K201391
• 510k Number: K201391
• Device Name: Easytech® Anatomical Shoulder System
• Classification: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
• Applicant: FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244
• Contact: Kathy Trier
• Correspondent: Kathy Trier; FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244
• Product Code: PKC
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-05-27
• Decision Date: 2021-02-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03701037313732	K201391	000
03701037301487	K201391	000
03701037301470	K201391	000
03701037301463	K201391	000