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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K173526
Device Name SENTIO MMG Gen 2
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Karen Sylvia
Correspondent
DePuy Synthes
325 Paramont Dr.
Raynham,  MA  02767
Correspondent Contact Anna D'Lima
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received11/14/2017
Decision Date 04/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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