K190811 is an FDA 510(k) clearance for the Optimus NEURO System - Sterile Kit. 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 November 27, 2019, 243 days after receiving the submission on March 29, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K190811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2019 |
| Decision Date | November 27, 2019 |
| Days to Decision | 243 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 |