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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K261374
Device Name LigaPASS™ System
Applicant
Medicrea International S.A.S
5389 Rte. De Strasbourg
Rillieux-La-Pape,  FR 69140
Applicant Contact Gautier Liegeon
Correspondent
Medicrea International S.A.S
5389 Rte. De Strasbourg
Rillieux-La-Pape,  FR 69140
Correspondent Contact Gautier Liegeon
Regulation Number888.3010
Classification Product Code
OWI  
Date Received04/27/2026
Decision Date 05/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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