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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 K232226
Device Name ARROW Off-Centred Humeral Insert
Applicant
FH Industrie
6 Rue Nobel, Zi De Kernevez
Quimper,  FR 29000
Applicant Contact Naoual Rahimi
Correspondent
MRC Global, LLC
9085 E. Mineral Cir
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3660
Classification Product Code
PHX  
Date Received07/27/2023
Decision Date 08/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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