The following data is part of a premarket notification filed by Osteonic Co., Ltd with the FDA for Optimus Neuro System - Sterile Kit.
| Device ID | K190811 |
| 510k Number | K190811 |
| Device Name: | Optimus NEURO System - Sterile Kit |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Osteonic Co., Ltd 505-3Ho, 1206Ho, 38, Digital-ro 29-gil, Guro-gu Seoul, KR 08381 |
| Contact | Choi Se Young |
| Correspondent | Choi Se Young Osteonic Co., Ltd 505-3Ho, 1206Ho, 38, Digital-ro 29-gil, Guro-gu Seoul, KR 08381 |
| Product Code | GWO |
| Subsequent Product Code | GRX |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809595972899 | K190811 | 000 |
| 08809595972882 | K190811 | 000 |
| 08809595972875 | K190811 | 000 |
| 08809595972868 | K190811 | 000 |
| 08809595972851 | K190811 | 000 |
| 08809595972844 | K190811 | 000 |
| 08809595972837 | K190811 | 000 |