CLEARED UNDER GRAFTON II EDBM

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Cleared Under Grafton Ii Edbm.

Pre-market Notification Details

Device IDK122513
510k NumberK122513
Device Name:CLEARED UNDER GRAFTON II EDBM
ClassificationFiller, Bone Void, Osteoinduction (w/o Human Growth Factor)
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKelly Anglin
CorrespondentKelly Anglin
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMBP  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-17
Decision Date2013-03-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169216242 K122513 000
00643169216235 K122513 000

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