The following data is part of a premarket notification filed by Medtronic with the FDA for Kyphon Xpede Bone Cement, Cd Horizon Fenestrated Screw Set.
| Device ID | K171938 |
| 510k Number | K171938 |
| Device Name: | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set |
| Classification | Bone Cement, Posterior Screw Augmentation |
| Applicant | Medtronic 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant Medtronic 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | PML |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-28 |
| Decision Date | 2017-10-23 |
| Summary: | summary |