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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 K191972
Device Name ARIX Wrist System
Applicant
Jeil Medical Corporation
702,703,704,705,706,804,805,807,812,815-Ho, 55,
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 08378
Applicant Contact Ahhyeon Woo
Correspondent
Jeil Medical Corporation
702,703,704,705,706,804,805,807,812,815-Ho, 55,
Digital-Ro34-Gil, Guro-Gu
Seoul,  KR 08378
Correspondent Contact Ahhyeon Woo
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   LXT  
Date Received07/24/2019
Decision Date 11/12/2019
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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