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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 K161864
Device Name ARIX Foot System
Applicant
Jeil Medical Corporation
#702, Kolon Science Valley 2nd
55, Digital-Ro 34, Guro-Gu
Seoul,  KR 152-728
Applicant Contact SEJIN RYU
Correspondent
Jeil Medical Corporation
#702, Kolon Science Valley 2nd
55, Digital-Ro 34, Guro-Gu
Seoul,  KR 152-728
Correspondent Contact SEJIN RYU
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/07/2016
Decision Date 08/02/2016
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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