510(k) K253377 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Expandable Titanium PLIF/TLIF System
| Applicant | Spectrum Spine, Inc., Jasper GA, US |
| Decision | Substantially Equivalent, Oct 24, 2025 |
| Received | Sep 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253377
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.