510(k) K251335 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Tera Lumbar Interbody Fusion System (Various PNs)
| Applicant | Acuity Surgical Devices, LLC, Irving TX, US |
| Decision | Substantially Equivalent, Jun 2, 2025 |
| Received | Apr 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251335
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.