MASTERGRAFT STRIP

Filler, Bone Void, Calcium Compound

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Mastergraft Strip.

Pre-market Notification Details

Device IDK082166
510k NumberK082166
Device Name:MASTERGRAFT STRIP
ClassificationFiller, Bone Void, Calcium Compound
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactMichelle Obenauer
CorrespondentMichelle Obenauer
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-31
Decision Date2009-06-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994487339 K082166 000
00613994407818 K082166 000
00613994407801 K082166 000
00643169719385 K082166 000
00643169719378 K082166 000
00643169719361 K082166 000
00643169486485 K082166 000
00643169486478 K082166 000
00643169486461 K082166 000

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