The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Hourglass Vertebral Body Spacer.
| Device ID | K033926 |
| 510k Number | K033926 |
| Device Name: | HOURGLASS 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 | 2003-12-18 |
| Decision Date | 2004-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902715556 | K033926 | 000 |
| 00763000885540 | K033926 | 000 |
| 00763000885557 | K033926 | 000 |
| 00763000885564 | K033926 | 000 |
| 00763000885571 | K033926 | 000 |
| 00763000885588 | K033926 | 000 |
| 00885074012766 | K033926 | 000 |
| 00721902715471 | K033926 | 000 |
| 00721902715488 | K033926 | 000 |
| 00721902715495 | K033926 | 000 |
| 00721902715501 | K033926 | 000 |
| 00721902715518 | K033926 | 000 |
| 00721902715525 | K033926 | 000 |
| 00721902715532 | K033926 | 000 |
| 00721902715549 | K033926 | 000 |
| 00763000885533 | K033926 | 000 |