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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K213978
Device Name TELIGEN System
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Daria Bochenek
Correspondent
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Correspondent Contact Daria Bochenek
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/20/2021
Decision Date 10/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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