MEDTRONIC DENTAL TCP

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 Medtronic Dental Tcp.

Pre-market Notification Details

Device IDK092087
510k NumberK092087
Device Name:MEDTRONIC DENTAL TCP
ClassificationBone Grafting Material, Synthetic
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactPamela Edwards
CorrespondentPamela Edwards
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 Received2009-07-09
Decision Date2009-12-30
Summary:summary

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