510(k) K253577 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
| Applicant | Medicrea International S.A.S. (Medtronic), Rillieux-La-Pape, FR |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Nov 17, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253577
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.