The following data is part of a premarket notification filed by Omnia Medical, Llc with the FDA for Omnia Medical Tibrid-sa.
| Device ID | K203207 |
| 510k Number | K203207 |
| Device Name: | Omnia Medical TiBrid-SA |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Omnia Medical, LLC 6 Canyon Rd, Suite 300 Morgantown, WV 26508 |
| Contact | Troy Schifano |
| Correspondent | Jordan Floyd JALEX Medical 27865 Clemens Rd, Suite 3 Westlake, OH 44145 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-30 |
| Decision Date | 2020-12-23 |