510(k) K202065 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
DOLOMITE Anterior Cervical Stabilization System
| Applicant | Astura Medical, LLC, Irving TX, US |
| Decision | Substantially Equivalent, Oct 26, 2020 |
| Received | Jul 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202065
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.