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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K173550
Device Name Akros FibuLink™ Syndesmosis Repair Kit
Applicant
Akros Medical
3503 Pleasant Green Rd.
Durham,  NC  27705
Applicant Contact Charles Horrell
Correspondent
Akros Medical
3503 Pleasant Green Rd.
Durham,  NC  27705
Correspondent Contact Charles Horrell
Regulation Number888.3030
Classification Product Code
HTN  
Date Received11/16/2017
Decision Date 12/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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