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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 K210360
Device Name Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
Applicant
Osteonic Co., Ltd.
1206ho, 38, Digital-Ro, 29-Gil, Guro-Gu
Seoul,  KR 08381
Applicant Contact Na Young Kang
Correspondent
Wise Company, Inc.
#507, #508, 166 Gasandigital 2-Ro, Geumcheon-Gu
Seoul,  KR 08507
Correspondent Contact Sanglok Lee
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received02/08/2021
Decision Date 01/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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