The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Kyphon Hv-r Bone Cement.
| Device ID | K180700 |
| 510k Number | K180700 |
| Device Name: | KYPHON HV-R Bone Cement |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Laveeda Leflore |
| Correspondent | Laveeda Leflore Medtronic Sofamor Danek USA, 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 | 2018-03-16 |
| Decision Date | 2018-05-18 |
| Summary: | summary |