510(k) K212653 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Catalyft LS Expandable Interbody System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 19, 2021 |
| Received | Aug 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant Open, Classified |
OVD | None listed |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant Open, Classified |
OVD | None listed |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant Open, Classified |
OVD | None listed |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant Open, Classified |
OVD | None listed |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant Open, Classified |
OVD | None listed |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant Open, Classified |
OVD | None listed |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit Open, Classified |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.