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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 K222229
Device Name Advanced LumFix Spinal Fixation System
Applicant
CG Bio Co., Ltd.
B1, 1f, 2f, C-Dong, 29, Jeyakdanji-Ro, Hyangnam-Eup
Hwaseong-Si,  KR 18608
Applicant Contact Iris Kim
Correspondent
CG Bio Co., Ltd.
B1, 1f, 2f, C-Dong, 29, Jeyakdanji-Ro, Hyangnam-Eup
Hwaseong-Si,  KR 18608
Correspondent Contact Iris Kim
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/25/2022
Decision Date 05/25/2023
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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