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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name washer, bolt nut
510(k) Number K112437
FOIA Releasable 510(k) K112437
Device Name ARTHREX FRACTURE SYSTEM
Applicant
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Applicant Contact COURTNEY SMITH
Correspondent
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Correspondent Contact COURTNEY SMITH
Regulation Number888.3030
Classification Product Code
HTN  
Subsequent Product Codes
HRS   HWC  
Date Received08/24/2011
Decision Date 12/21/2011
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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