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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K183352
Device Name Optimus Neuro System
Applicant
Osteonic Co., Ltd.
505-3ho, 1206ho, Digital-Ro 29-Gil, Guro-Gu
Seoul,  KR 08381
Applicant Contact Seyoung Choi
Correspondent
Bt Solutions, Inc.
904, Eonju-Ro 68-Gil 5, Gangnam-Gu
Seoul,  KR 06210
Correspondent Contact Jung Hyeon Park
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received12/03/2018
Decision Date 01/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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