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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K160731
Device Name LumFix Spinal Fixation Sytem
Applicant
CG Bio Co., Ltd.
244 Galmachi-Ro, Jungwon-Gu
Seongnam-Si,  KR 13211
Applicant Contact YUNA JEONG
Correspondent
Withus Group, Inc.
2531 Pepperdale Dr.
Rowland Heights,  CA  91748
Correspondent Contact APRIL LEE
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received03/17/2016
Decision Date 10/04/2016
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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