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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 K132876
Device Name ARIX HAND LOCKING SYSTEM
Applicant
Jeil Medical Corporation
#702, Kolon Science Valley 2nd
811, Guro-Dong, Guro-Gu
Seoul,  KR 152-050
Applicant Contact HYEROUNG LEE
Correspondent
Jeil Medical Corporation
#702, Kolon Science Valley 2nd
811, Guro-Dong, Guro-Gu
Seoul,  KR 152-050
Correspondent Contact HYEROUNG LEE
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/13/2013
Decision Date 12/18/2013
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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