MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX

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 Mastergraft Strip; Mastergraft Ultramatrix.

Pre-market Notification Details

Device IDK130335
510k NumberK130335
Device Name:MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX
ClassificationFiller, Bone Void, Calcium Compound
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRyan Massey
CorrespondentRyan Massey
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-11
Decision Date2013-04-19
Summary:summary

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