510(k) K192049 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Oryx Cervical Plate System
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 8, 2019 |
| Received | Jul 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2020 | Innovasis, Inc Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation. Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.