510(k) K243816 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Testa TP Pivoting Spacer System
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Jun 27, 2025 |
| Received | Dec 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243816
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.