T2 STRATOSPHERE™ Expandable Corpectomy System
Spinal Vertebral Body Replacement Device
Medtronic Sofamor Danek, USA Inc.
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.
Pre-market Notification Details
| Device ID | K181328 |
| 510k Number | K181328 |
| 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 | Kanesha Hines |
| Correspondent | Kanesha Hines 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 | 2018-05-18 |
| Decision Date | 2018-09-19 |
| Summary: | summary |
Trademark Results [T2 STRATOSPHERE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T2 STRATOSPHERE 86817545 5546279 Live/Registered |
Warsaw Orthopedic, Inc. 2015-11-12 |
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