K210360 is an FDA 510(k) clearance for the 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). This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II - Special Controls, product code GWO).
Submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 27, 2022, 353 days after receiving the submission on February 8, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K210360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2021 |
| Decision Date | January 27, 2022 |
| Days to Decision | 353 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWO — Plate, Cranioplasty, Preformed, Alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5320 |