MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT

Filler, Bone Void, Calcium Compound

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Magnifuse Bone Graft, Magifuse Ii Bone Graft.

Pre-market Notification Details

Device IDK131673
510k NumberK131673
Device Name:MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
ClassificationFiller, Bone Void, Calcium Compound
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKelly Anglin
CorrespondentKelly Anglin
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-07
Decision Date2013-10-03
Summary:summary

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