510(k) K241164 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
IB3D PL Spinal System
| Applicant | Medicrea International S.A.S. (Medtronic), Rillieux-La-Pape, FR |
| Decision | Substantially Equivalent, Sep 6, 2024 |
| Received | Apr 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | Medicrea International Medicrea, IB3D Universal Implant Inserter, Rx Only
REF: A24000000 Open, Classified |
MAX | None listed |
| Jan 9, 2026 | Medicrea International Medicrea, IB3D PL Instruments Set, Rx Only
REF: SPS03174 Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.