510(k) K250773 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Luna® Ti Interbody Fusion System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 4, 2026 |
| Received | Mar 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250773
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.