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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K200791
Device Name Navigation Enabled Intruments
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Daria Bochenek
Correspondent
Depuy Synthes Spine
Eimattstrasse 3
Oberdorf,  CH 4436
Correspondent Contact Nicole Aeschbacher
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/26/2020
Decision Date 07/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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