K-numberK210360
Device nameNeuro 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)
ApplicantOsteonic Co., Ltd.
Product codeGWO
Device classClass II
Decision dateJan 27, 2022
DecisionSubstantially Equivalent
Regulation882.5320
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