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 |