Osteonic Co., Ltd. · Class II · Cleared Jan 27, 2022
| 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. |
| Product code | GWO |
| Device class | Class II |
| Decision date | Jan 27, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 882.5320 |
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