The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Kyphx Hv-r Bone Cement, Model C01a.
| Device ID | K041584 |
| 510k Number | K041584 |
| Device Name: | KYPHX HV-R BONE CEMENT, MODEL C01A |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus KYPHON, INC. 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 | 2004-06-14 |
| Decision Date | 2004-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994745606 | K041584 | 000 |
| 00613994745590 | K041584 | 000 |
| 00613994745569 | K041584 | 000 |
| 00613994745552 | K041584 | 000 |
| 00613994583215 | K041584 | 000 |
| 00613994515155 | K041584 | 000 |
| 00643169097865 | K041584 | 000 |
| 00643169097834 | K041584 | 000 |