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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K221031
Device Name Arthrex DualCompression Hindfoot Fusion Nail Implant System
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Applicant Contact Rebecca R. Homan
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Correspondent Contact Rebecca R. Homan
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/07/2022
Decision Date 12/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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