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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
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