510(k) K253894 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
BMD Titanium Spinal Fusion System
| Applicant | Global Biomedica s.r.o., Ceský Teín, CZ |
| Decision | Substantially Equivalent, May 28, 2026 |
| Received | Dec 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253894
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.