MASTERGRAFT PUTTY

Bone Grafting Material, Synthetic

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 Putty.

Pre-market Notification Details

Device IDK140374
510k NumberK140374
Device Name:MASTERGRAFT PUTTY
ClassificationBone Grafting Material, Synthetic
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 CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-14
Decision Date2014-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169486454 K140374 000
00885074478753 K140374 000
00885074478760 K140374 000
00885074478784 K140374 000
00885074478791 K140374 000
00643169486416 K140374 000
00643169486423 K140374 000
00643169486430 K140374 000
00643169486447 K140374 000
00885074478715 K140374 000

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