The following data is part of a premarket notification filed by Medtronic with the FDA for Kyphon Xpede Bone Cement.
Device ID | K102397 |
510k Number | K102397 |
Device Name: | KYPHON XPEDE BONE CEMENT |
Classification | Cement, Bone, Vertebroplasty |
Applicant | Medtronic 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
Contact | Mary Rose |
Correspondent | Mary Rose Medtronic 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
Product Code | NDN |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-24 |
Decision Date | 2011-02-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994831507 | K102397 | 000 |
00643169097803 | K102397 | 000 |
00643169097797 | K102397 | 000 |