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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 Gasan digital 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
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