The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Kyphon Xpede Bone Cement.
Device ID | K163032 |
510k Number | K163032 |
Device Name: | Kyphon Xpede Bone Cement |
Classification | Cement, Bone, Vertebroplasty |
Applicant | Medtronic Inc. 1800 Pyramid Place Memphis, TN 38132 |
Contact | Pamela Edwards |
Correspondent | Pamela Edwards Medtronic Inc. 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 | 2016-10-31 |
Decision Date | 2017-02-27 |
Summary: | summary |