510(k) K203207 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Omnia Medical TiBrid-SA
| Applicant | Omnia Medical, LLC, Morgantown, WV, US |
| Decision | Substantially Equivalent, Dec 23, 2020 |
| Received | Oct 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203207
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2025 | Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree. Open, Classified |
OVD | None listed |
| Sep 11, 2025 | Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles. Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.