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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 K172206
Device Name NAJA™ Ligament Correction System
Applicant
Cousin Biotech Sas
8 Rue De L'Abbe Bonpain
Wervicq-Sud,  FR 59117
Applicant Contact Mathilde Collet
Correspondent
Cousin Biotech Sas
8 Rue De L'Abbe Bonpain
Wervicq-Sud,  FR 59117
Correspondent Contact Franck Pelletier
Regulation Number888.3010
Classification Product Code
OWI  
Date Received07/21/2017
Decision Date 04/10/2018
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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