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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 K172021
Device Name LigaPASS
Applicant
Medicrea International SA
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact David Ryan
Correspondent
Medicrea International SA
5389 Route De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact David Ryan
Regulation Number888.3010
Classification Product Code
OWI  
Date Received07/05/2017
Decision Date 08/30/2017
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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