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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K243004
Device Name Xpine Spinal Fixation 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 Jinwoo Kim Kim
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 Jinwoo Kim Kim
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/26/2024
Decision Date 11/08/2024
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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