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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K163182
Device Name Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
Applicant
Medtronic Powered Surgical Solutions
4620 N. Beach St.
Fort Worth,  TX  76177
Applicant Contact Deep Pal
Correspondent
Medtronic Powered Surgical Solutions
4620 N. Beach St.
Fort Worth,  TX  76177
Correspondent Contact Deep Pal
Regulation Number882.4370
Classification Product Code
HBB  
Subsequent Product Codes
DWH   EQJ   ERL   GET   HBE  
HSZ   KFK  
Date Received11/14/2016
Decision Date 03/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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