K183352 is an FDA 510(k) clearance for the Optimus Neuro System. 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 2, 2019, 30 days after receiving the submission on December 3, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K183352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2018 |
| Decision Date | January 02, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |