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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, Nondegradable, Soft Tissue
510(k) Number K180118
Device Name Arthrex NanoSuture Anchor
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -5553
Applicant Contact Rebecca R. Homan
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -5553
Correspondent Contact Rebecca R. Homan
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/16/2018
Decision Date 02/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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