PROGENIX DBM PUTTY

Bone Grafting Material, Human Source

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Progenix Dbm Putty.

Pre-market Notification Details

Device IDK080462
510k NumberK080462
Device Name:PROGENIX DBM PUTTY
ClassificationBone Grafting Material, Human Source
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactMichelle Obenauer
CorrespondentMichelle Obenauer
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNUN  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-20
Decision Date2008-05-13
Summary:summary

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