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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 K231887
Device Name ARIX Ankle Distal Tibia System
Applicant
Jeil Medical Corporation
702-703-704-705-706-804-805-807-812-815-Ho, 55
Digital-Ro 34-Gil, Guro-Gu
Seoul,  KR 08378
Applicant Contact Dajung Lee
Correspondent
Jeil Medical Corporation
702-703-704-705-706-804-805-807-812-815-Ho, 55
Digital-Ro 34-Gil, Guro-Gu
Seoul,  KR 08378
Correspondent Contact Dajung Lee
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/27/2023
Decision Date 12/14/2023
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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