Kyphon HV-R Bone Cement

Cement, Bone, Vertebroplasty

MEDTRONIC INC

The following data is part of a premarket notification filed by Medtronic Inc with the FDA for Kyphon Hv-r Bone Cement.

Pre-market Notification Details

Device IDK160983
510k NumberK160983
Device Name:Kyphon HV-R Bone Cement
ClassificationCement, Bone, Vertebroplasty
Applicant MEDTRONIC INC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactPamela Edwards
CorrespondentPamela Edwards
MEDTRONIC INC 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-07
Decision Date2016-08-24
Summary:summary

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