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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K192417
Device Name ARIX Cannulated Screw 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 38378
Applicant Contact sejin ryu
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 sejin ryu
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/04/2019
Decision Date 11/26/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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