The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Basis Vertebral Body Spacer.
| Device ID | K051105 |
| 510k Number | K051105 |
| Device Name: | BASIS VERTEBRAL BODY SPACER |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 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 | 2005-05-02 |
| Decision Date | 2005-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074104843 | K051105 | 000 |
| 00885074104836 | K051105 | 000 |
| 00885074104829 | K051105 | 000 |
| 00885074104805 | K051105 | 000 |
| 00885074104782 | K051105 | 000 |