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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K202024
Device Name ARROW Short Stem Humeral System
Applicant
FH Industrie
6 Rue Nobel, Zi De Kernevez
Quimper,  FR 29000
Applicant Contact Patricia Donnard
Correspondent
MRC Global, LLC
9085 E. Mineral Cir
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received07/22/2020
Decision Date 11/30/2021
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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