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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K143749
Device Name Arthrex Distal Radius System
Applicant
Arthrex, Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Laura Medlin
Correspondent
Arthrex, Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Laura Medlin
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/31/2014
Decision Date 04/03/2015
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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