510(k) K260385 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
| Applicant | Carlsmed, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 9, 2026 |
| Received | Feb 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260385
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.