510(k) K210425 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Catalyft PL Expandable Interbody System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 24, 2021 |
| Received | Feb 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2025 | Medtronic Sofamor Danek USA Inc Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers:
1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073.
2. SPACER 6068076 CATALYFT PL LONG Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.