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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K252251
Device Name EASYMADE-TI
Applicant
CG Bio Co., Ltd.
3rd Floor, Hannam Bd. 211, Itaewon-Ro, Yongsan-Gu
Seoul,  KR 04349
Applicant Contact Youngwook Moon
Correspondent
CG Bio Co., Ltd.
3rd Floor, Hannam Bd. 211, Itaewon-Ro, Yongsan-Gu
Seoul,  KR 04349
Correspondent Contact Youngwook Moon
Regulation Number882.5330
Classification Product Code
GXN  
Date Received07/18/2025
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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