510(k) K192492 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
EL CAPITAN Anterior Lumber Interbody System
| Applicant | Astura Medical, LLC, Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 21, 2020 |
| Received | Sep 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192492
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.