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 IDK182436
510k NumberK182436
Device Name:POWEREASE System
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactAnkit K. Shah
CorrespondentAnkit K. Shah
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeHBE  
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-07
Decision Date2018-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169868724 K182436 000
00763000025199 K182436 000
00763000015305 K182436 000

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