The following data is part of a premarket notification filed by Ilion Medical Inc with the FDA for Nadia Si Fusion System.
| Device ID | K190580 |
| 510k Number | K190580 |
| Device Name: | NADIA SI Fusion System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Ilion Medical Inc 825 Nicollet Mall Suite 715 Minneapolis, MN 55402 |
| Contact | Tania Fuentes-davitt |
| Correspondent | Tania Fuentes-davitt Ilion Medical Inc. 825 Nicollet Mall Suite 715 Minneapolis, MN 55402 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2020-08-05 |