The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for T2 Spinal System.
| Device ID | K091883 |
| 510k Number | K091883 |
| Device Name: | T2 SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Theresa Leister |
| Correspondent | Theresa Leister MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-24 |
| Decision Date | 2009-09-21 |
| Summary: | summary |