510(k) K213935 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
PISCES-SA Standalone ALIF Interbody System
| Applicant | Osseus Fusion Systems, Dallas TX, US |
| Decision | Substantially Equivalent, May 6, 2022 |
| Received | Dec 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213935
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.