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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K253115
Device Name LARS ACJ
Applicant
Movmedix S.A.S.
5 Rue De La Fontaine
Arc-Sur-Tille,  FR 21560
Applicant Contact Luisa Arcos
Correspondent
Movmedix S.A.S.
5 Rue De La Fontaine
Arc-Sur-Tille,  FR 21560
Correspondent Contact Luisa Arcos
Regulation Number888.3030
Classification Product Code
HTN  
Subsequent Product Code
MBI  
Date Received09/24/2025
Decision Date 06/10/2026
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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