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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K151468
Device Name ARIX Wrist System
Applicant
Jeil Medical Corporation
702.703.704.705.706.804.805.807.812-Ho, 55
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 152-728
Applicant Contact Jiwon Kang
Correspondent
Jeil Medical Corporation
702.703.704.705.706.804.805.807.812-Ho, 55
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 152-728
Correspondent Contact Sejin Ryu
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/01/2015
Decision Date 01/14/2016
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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