The following data is part of a premarket notification filed by Omnia Medical, Llc with the FDA for Omnia Medical Vbr.
| Device ID | K191778 |
| 510k Number | K191778 |
| Device Name: | Omnia Medical VBR |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | Omnia Medical, LLC 6 Canyon Rd Suite 300 Morgantown, WV 26508 |
| Contact | Troy Schifano |
| Correspondent | Daniel Johnson JALEX Medical 30311 Clemens Rd Suite 5D Westlake, OH 44145 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-02 |
| Decision Date | 2019-08-28 |