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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 K254157
Device Name CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Marina Minnock
Correspondent
Synthes GmbH
Eimattstrasse 3
Oberdorf,  CH 4436
Correspondent Contact Marina Minnock
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/22/2025
Decision Date 05/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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