510(k) K243386 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Ventris Intervertebral Body Fusion Device
| Applicant | Acuity Surgical Devices, LLC, Irving TX, US |
| Decision | Substantially Equivalent, Apr 22, 2025 |
| Received | Oct 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243386
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.