MR8 Drill System

Motor, Drill, Electric

MEDTRONIC POWERED SURGICAL SOLUTIONS

The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Mr8 Drill System.

Pre-market Notification Details

Device IDK163565
510k NumberK163565
Device Name:MR8 Drill System
ClassificationMotor, Drill, Electric
Applicant MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST. Fort Worth,  TX  76137
ContactDeep Pal
CorrespondentJohn Connor
MEDTRONIC NAVIGATION 826 COAL CREEK CIRCLE Louisville,  CO  80027
Product CodeHBC  
Subsequent Product CodeERL
Subsequent Product CodeHBB
Subsequent Product CodeHBE
Subsequent Product CodeHSZ
CFR Regulation Number882.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-19
Decision Date2017-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169912137 K163565 000

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