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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K180763
Device Name CuffLink Implant System Biocomposite
Applicant
CONMED Corporation
525 French Road
Utica,  NY  13502
Applicant Contact Diana L. Nader-Martone
Correspondent
CONMED Corporation
525 French Road
Utica,  NY  13502
Correspondent Contact Diana L. Nader-Martone
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received03/23/2018
Decision Date 07/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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