The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Optimus Neuro System.
| Device ID | K141911 |
| 510k Number | K141911 |
| Device Name: | OPTIMUS NEURO SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | OSTEONIC CO., LTD. 2651 E CHAPMAN AVE. STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung OSTEONIC CO., LTD. 2651 E CHAPMAN AVE. STE 110 Fullerton, CA 92831 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2015-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809595972691 | K141911 | 000 |
| 08809416061665 | K141911 | 000 |
| 08809416061658 | K141911 | 000 |
| 08809416061627 | K141911 | 000 |
| 08809416061603 | K141911 | 000 |
| 08809416061580 | K141911 | 000 |
| 08809416061573 | K141911 | 000 |
| 08809416061566 | K141911 | 000 |
| 08809416061559 | K141911 | 000 |
| 08809416061542 | K141911 | 000 |
| 08809416061535 | K141911 | 000 |
| 08809399745286 | K141911 | 000 |
| 08809399745279 | K141911 | 000 |
| 08809399745255 | K141911 | 000 |
| 08809399745248 | K141911 | 000 |
| 08809399745231 | K141911 | 000 |
| 08809416061672 | K141911 | 000 |
| 08809416061689 | K141911 | 000 |
| 08809416061917 | K141911 | 000 |
| 08809416061900 | K141911 | 000 |
| 08809416061887 | K141911 | 000 |
| 08809416061856 | K141911 | 000 |
| 08809416061849 | K141911 | 000 |
| 08809416061832 | K141911 | 000 |
| 08809416061825 | K141911 | 000 |
| 08809416061818 | K141911 | 000 |
| 08809416061801 | K141911 | 000 |
| 08809416061795 | K141911 | 000 |
| 08809416061788 | K141911 | 000 |
| 08809416061726 | K141911 | 000 |
| 08809416061719 | K141911 | 000 |
| 08809416061702 | K141911 | 000 |
| 08809416061696 | K141911 | 000 |
| 08809539691695 | K141911 | 000 |