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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K201391
Device Name Easytech® Anatomical Shoulder System
Applicant
Fx Shoulder USA, Inc.
13465 Midway Rd.
Suite 101
Dallas,  TX  75244
Applicant Contact Kathy Trier
Correspondent
Fx Shoulder USA, Inc.
13465 Midway Rd.
Suite 101
Dallas,  TX  75244
Correspondent Contact Kathy Trier
Regulation Number888.3660
Classification Product Code
PKC  
Date Received05/27/2020
Decision Date 02/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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