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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 K200361
Device Name Akros Scruture Anchor LisFranc 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 Received02/14/2020
Decision Date 04/06/2020
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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