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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 K170501
Device Name CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
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  
Date Received02/21/2017
Decision Date 03/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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