The following data is part of a premarket notification filed by Medtronic Sofamor Danck Usa, Inc. with the FDA for Kyphon (r) Hv-r(r) Bone Cement.
Device ID | K150460 |
510k Number | K150460 |
Device Name: | KYPHON (R) HV-R(R) Bone Cement |
Classification | Cement, Bone, Vertebroplasty |
Applicant | MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Kathy L. Remsen |
Correspondent | Kathy L. Remsen 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 | 2015-02-23 |
Decision Date | 2015-04-28 |
Summary: | summary |