The following data is part of a premarket notification filed by Osteonic Co., Ltd with the FDA for Optimus Neuro System.
| Device ID | K183352 |
| 510k Number | K183352 |
| Device Name: | Optimus Neuro System |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Osteonic Co., Ltd 505-3Ho, 1206Ho, Digital-ro 29-gil, Guro-gu Seoul, KR 08381 |
| Contact | Seyoung Choi |
| Correspondent | Jung Hyeon Park BT Solutions, Inc. 904, Eonju-ro 68-gil 5, Gangnam-gu Seoul, KR 06210 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809595972721 | K183352 | 000 |
| 08809595972714 | K183352 | 000 |
| 08809595972707 | K183352 | 000 |
| 08809416061870 | K183352 | 000 |
| 08809416061863 | K183352 | 000 |
| 08809416061733 | K183352 | 000 |
| 08809416061641 | K183352 | 000 |
| 08809416061634 | K183352 | 000 |
| 08809399740953 | K183352 | 000 |
| 08809595972745 | K183352 | 000 |
| 08809595972769 | K183352 | 000 |
| 08809595972998 | K183352 | 000 |
| 08809595972981 | K183352 | 000 |
| 08809595972974 | K183352 | 000 |
| 08809595972967 | K183352 | 000 |
| 08809595972950 | K183352 | 000 |
| 08809595972820 | K183352 | 000 |
| 08809595972806 | K183352 | 000 |
| 08809595972783 | K183352 | 000 |
| 08809399740946 | K183352 | 000 |