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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K252327
Device Name CMORE® CT System; CMORE® CT System Navigated Instruments
Applicant
Icotec AG
Industriestrasse 12
Altstaetten,  CH 9450
Applicant Contact Vanessa Faessler
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Michael Coladonato
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
OLO  
Date Received07/25/2025
Decision Date 11/12/2025
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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