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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K182489
Device Name 4CIS® Pinehurst Anterior Cervical Plate system
Applicant
Solco Biomedical Co., Ltd.
154 Seotan-Ro, Seotan-Myeon
Pyeongtaek,  KR 17704
Applicant Contact Il Kim
Correspondent
First Gold Corp.
14110 Dallas Pkwy., Suite 135
Dallas,  TX  75254
Correspondent Contact Hwi Joon Park
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/11/2018
Decision Date 01/16/2019
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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