The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Catalyft Ls Expandable Interbody System.
| Device ID | K212653 |
| 510k Number | K212653 |
| Device Name: | Catalyft LS Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Madhuvanthi Soundirarajan |
| Correspondent | Madhuvanthi Soundirarajan Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | MAX |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2021-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000552435 | K212653 | 000 |
| 00763000465940 | K212653 | 000 |
| 00763000465933 | K212653 | 000 |
| 00763000465926 | K212653 | 000 |
| 00763000465919 | K212653 | 000 |
| 00763000465902 | K212653 | 000 |
| 00763000465896 | K212653 | 000 |
| 00763000465889 | K212653 | 000 |
| 00763000465872 | K212653 | 000 |
| 00763000465957 | K212653 | 000 |
| 00763000465964 | K212653 | 000 |
| 00763000465971 | K212653 | 000 |
| 00763000552428 | K212653 | 000 |
| 00763000518363 | K212653 | 000 |
| 00763000518356 | K212653 | 000 |
| 00763000466084 | K212653 | 000 |
| 00763000466077 | K212653 | 000 |
| 00763000466060 | K212653 | 000 |
| 00763000465995 | K212653 | 000 |
| 00763000465988 | K212653 | 000 |
| 00763000465865 | K212653 | 000 |