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 |