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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 K212756
Device Name Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Nicole Aeschbacher
Correspondent
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Correspondent Contact Nicole Aeschbacher
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/31/2021
Decision Date 05/05/2022
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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