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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 K161746
Device Name ARIX Hand System
Applicant
Jeil Medical Corporation
Seoul,  KR 152-728
Applicant Contact Seungyong Lee
Correspondent
Jeil Medical Corporation
Seoul,  KR 152-728
Correspondent Contact Seungyong Lee
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/24/2016
Decision Date 09/21/2016
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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