Device Classification Name |
Motor, Drill, Electric
|
510(k) Number |
K163565 |
Device Name |
MR8 Drill System |
Applicant |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
4620 NORTH BEACH ST. |
FORT WORTH,
TX
76137
|
|
Applicant Contact |
Deep Pal |
Correspondent |
MEDTRONIC NAVIGATION |
826 COAL CREEK CIRCLE |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
John Connor |
Regulation Number | 882.4360
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/19/2016 |
Decision Date | 03/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|