510(k) K210360

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) by Osteonic Co., Ltd. — Product Code GWO

K210360 is an FDA 510(k) premarket notification submitted by Osteonic Co., Ltd. for the device "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)". The FDA issued a decision of Substantially Equivalent on January 27, 2022. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Osteonic Co., Ltd. has at least 10 other 510(k) clearances on record.