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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 K170313
Device Name ARIX Ankle Distal Tibia 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  
Subsequent Product Code
HWC  
Date Received02/01/2017
Decision Date 07/27/2017
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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