510(k) K251829 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
DeGen Medical Patient Specific Implant (PSI) System
| Applicant | Degen Medical, Florence SC, US |
| Decision | Substantially Equivalent, Dec 8, 2025 |
| Received | Jun 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251829
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.