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 |