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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K252153
Device Name FFX Facet Fixation System
Applicant
Sc Medica
3 Quai Kleber - Tour Sebastopol
Strasbourg,  FR
Applicant Contact Camille Srour
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Classification Product Code
MRW  
Date Received07/09/2025
Decision Date 10/16/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT05645497
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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