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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K242247
Device Name ARIX Femur Nail 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 Number888.3020
Classification Product Code
HSB  
Date Received07/31/2024
Decision Date 04/22/2025
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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