KYPHON (R) HV-R(R) Bone Cement

Cement, Bone, Vertebroplasty

MEDTRONIC SOFAMOR DANCK USA, INC.

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.

Pre-market Notification Details

Device IDK150460
510k NumberK150460
Device Name:KYPHON (R) HV-R(R) Bone Cement
ClassificationCement, Bone, Vertebroplasty
Applicant MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKathy L. Remsen
CorrespondentKathy L. Remsen
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-23
Decision Date2015-04-28
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.