The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc. with the FDA for Catalyft Pl Expandable Interbody System.
| Device ID | K210425 |
| 510k Number | K210425 |
| Device Name: | Catalyft PL Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Alex Underberg |
| Correspondent | Alex Underberg Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2021-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000292195 | K210425 | 000 |
| 00763000246761 | K210425 | 000 |
| 00763000246754 | K210425 | 000 |
| 00763000246730 | K210425 | 000 |
| 00763000246723 | K210425 | 000 |
| 00763000246709 | K210425 | 000 |
| 00763000246693 | K210425 | 000 |
| 00763000246518 | K210425 | 000 |
| 00763000239374 | K210425 | 000 |
| 00763000239367 | K210425 | 000 |
| 00763000239350 | K210425 | 000 |
| 00763000239343 | K210425 | 000 |
| 00763000239336 | K210425 | 000 |
| 00763000239329 | K210425 | 000 |
| 00763000229221 | K210425 | 000 |
| 00763000246785 | K210425 | 000 |
| 00763000246792 | K210425 | 000 |
| 00763000255299 | K210425 | 000 |
| 00763000255282 | K210425 | 000 |
| 00763000255275 | K210425 | 000 |
| 00763000255268 | K210425 | 000 |
| 00763000255251 | K210425 | 000 |
| 00763000255244 | K210425 | 000 |
| 00763000255237 | K210425 | 000 |
| 00763000253554 | K210425 | 000 |
| 00763000253547 | K210425 | 000 |
| 00763000253530 | K210425 | 000 |
| 00763000246853 | K210425 | 000 |
| 00763000246846 | K210425 | 000 |
| 00763000246822 | K210425 | 000 |
| 00763000246815 | K210425 | 000 |
| 00763000229214 | K210425 | 000 |