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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K192044
Device Name 4CIS Marlin PEEK ACIF Cage
Applicant
Solco Biomedical Co., Ltd.
154 Seotan-Ro, Seotan-Myeon
Pyeongtaek-Si,  KR 17704
Applicant Contact Hwi-geun Yu
Correspondent
Solco Biomedical Co., Ltd.
154 Seotan-Ro, Seotan-Myeon
Pyeongtaek-Si,  KR 17704
Correspondent Contact Hwi-geun Yu
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/31/2019
Decision Date 12/19/2019
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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