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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 K223438
Device Name TELIGEN System Peripheral Motor Nerve Stimulation Indications
Applicant
Medos International SARL
Chemin Blanc 38
Le Locle,  CH 2400
Applicant Contact Daria Bochenek
Correspondent
Synthes GmbH
Eimattstrasse 3
Oberdorf,  CH CH-4436
Correspondent Contact Daria Bochenek
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Codes
HRX   OLO  
Date Received11/14/2022
Decision Date 02/10/2023
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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