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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 K141735
Device Name ARTHREX ANKLE FUSION PLATING SYSTEM
Applicant
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Applicant Contact LAURA MEDLIN
Correspondent
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Correspondent Contact LAURA MEDLIN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received06/27/2014
Decision Date 08/15/2014
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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