510(k) K261049 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SCALA® TL
| Applicant | Spineart SA, Plan-Les-Ouates, CH |
| Decision | Substantially Equivalent, Aug 20, 2026 |
| Received | Mar 31, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261049
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.