510(k) K261353 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
| Applicant | Kyocera Medical Technologies, Inc., Redlands CA, US |
| Decision | Substantially Equivalent, Jul 15, 2026 |
| Received | Apr 24, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261353
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.