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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843511122294 | K203207 | 000 |
| 00843511113049 | K203207 | 000 |
| 00843511113032 | K203207 | 000 |
| 00843511113018 | K203207 | 000 |
| 00843511113001 | K203207 | 000 |
| 00843511112998 | K203207 | 000 |
| 00843511112974 | K203207 | 000 |
| 00843511112967 | K203207 | 000 |
| 00843511112660 | K203207 | 000 |
| 00843511112653 | K203207 | 000 |
| 00843511112646 | K203207 | 000 |
| 00843511112639 | K203207 | 000 |
| 00843511112622 | K203207 | 000 |
| 00843511112615 | K203207 | 000 |
| 00843511111816 | K203207 | 000 |
| 00843511111809 | K203207 | 000 |
| 00843511122133 | K203207 | 000 |
| 00843511113056 | K203207 | 000 |
| 00843511113063 | K203207 | 000 |
| 00843511113070 | K203207 | 000 |
| 00843511122287 | K203207 | 000 |
| 00843511122096 | K203207 | 000 |
| 00843511122089 | K203207 | 000 |
| 00843511122072 | K203207 | 000 |
| 00843511122065 | K203207 | 000 |
| 00843511122058 | K203207 | 000 |
| 00843511122041 | K203207 | 000 |
| 00843511121853 | K203207 | 000 |
| 00843511121846 | K203207 | 000 |
| 00843511121839 | K203207 | 000 |
| 00843511113162 | K203207 | 000 |
| 00843511113131 | K203207 | 000 |
| 00843511113124 | K203207 | 000 |
| 00843511113117 | K203207 | 000 |
| 00843511113100 | K203207 | 000 |
| 00843511113087 | K203207 | 000 |
| 00843511122126 | K203207 | 000 |