510(k) K193320 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
| Applicant | Kyocera Medical Technologies, Inc., Redlands CA, US |
| Decision | Substantially Equivalent, Feb 4, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193320
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.