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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K251959
Device Name TnR Cranial Implant
Applicant
T&R BIOFAB CO., Ltd.
96, Mayu-Ro, Siheung-Si
Gyeonggi-Do,  KR 15111
Applicant Contact Chaewon Park
Correspondent
K-Bio Solutions
Suite 701, Lawyers Tower, 125 Seochojungang-Ro, Seocho-Gu
Seoul,  KR 06644
Correspondent Contact Juyeon Ryu
Regulation Number882.5300
Classification Product Code
GXP  
Date Received06/26/2025
Decision Date 07/30/2026
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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