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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K231251
Device Name FlexWing Anterior Cervical Plate 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 Sejin Ryu
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 Sejin Ryu
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/01/2023
Decision Date 07/24/2024
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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