The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Kyphx Hv-r, Model C01a.
| Device ID | K033801 |
| 510k Number | K033801 |
| Device Name: | KYPHX HV-R, MODEL C01A |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | KYPHON, INC. 1350 BORDEAUX DR. Sunnyvale, CA 94089 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus KYPHON, INC. 1350 BORDEAUX DR. 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 | 2003-12-08 |
| Decision Date | 2004-04-01 |
| Summary: | summary |