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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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