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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 K180662
Device Name Arthrex FastThread Interference Screw
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Jessica L. Singelais
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Jessica L. Singelais
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received03/14/2018
Decision Date 05/22/2018
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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