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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 K212683
Device Name GLOBAL ICON Stemless Shoulder System
Applicant
Depuy(Ireland)
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Kathy Harris
Correspondent
DePuy Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Megan Bernier
Regulation Number888.3660
Classification Product Code
PKC  
Date Received08/24/2021
Decision Date 01/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT03168672
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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