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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 K190471
Device Name 4CIS® Chiron Spinal Fixation System
Applicant
Solco Biomedical Co., Ltd.
154 Seotan-Ro, Seotan-Myeon
Pyeongtaek,  KR 17704
Applicant Contact Kim Il
Correspondent
First Gold Corp.
154, Seotan-Ro, Gyeonggi-Do
Pyeongtaek-Si,
Gyeonggi-Do,  KR 17704
Correspondent Contact Hwi-Geun Yu
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/26/2019
Decision Date 07/24/2019
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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