The following data is part of a premarket notification filed by Medtronic with the FDA for Kyphon Xpede Bone Cement.
| Device ID | K151227 |
| 510k Number | K151227 |
| Device Name: | KYPHON XPEDE Bone Cement |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | MEDTRONIC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Kathy L Remsen |
| Correspondent | Kathy L Remsen MEDTRONIC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-07 |
| Decision Date | 2015-11-16 |
| Summary: | summary |