The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc. with the FDA for T2 Stratosphere Expandable Corpectomy System.
| Device ID | K183510 |
| 510k Number | K183510 |
| Device Name: | T2 STRATOSPHERE Expandable Corpectomy System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Elizabeth Hamilton |
| Correspondent | Elizabeth Hamilton Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-18 |
| Decision Date | 2019-01-16 |
| Summary: | summary |