POWEREASE SYSTEM

Drills, Burrs, Trephines & Accessories (simple, Powered)

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 Powerease System.

Pre-market Notification Details

Device IDK123270
510k NumberK123270
Device Name:POWEREASE SYSTEM
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactJulie Bassett
CorrespondentJulie Bassett
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeHBE  
Subsequent Product CodeGWF
Subsequent Product CodeHWE
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-19
Decision Date2013-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169013117 K123270 000
00643169013100 K123270 000

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