510(k) K212980 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Tesera-k ALIF System
| Applicant | Kyocera Medical Technologies, Inc., Redlands CA, US |
| Decision | Substantially Equivalent, Jan 7, 2022 |
| Received | Sep 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212980
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.