FDA 510(k) Applications Submitted by Osteonic Co., Ltd

FDA 510(k) Number Submission Date Device Name Applicant
K190811 03/29/2019 Optimus NEURO System - Sterile Kit Osteonic Co., Ltd
K210360 02/08/2021 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) Osteonic Co., Ltd
K183352 12/03/2018 Optimus Neuro System Osteonic Co., Ltd


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