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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 K111253
Device Name ARTHREX DISTAL EXTREMITY PLATE SYSTEM
Applicant
ARTHREX, INC.
1370 creekside blvd.
naples,  FL  34108 1945
Contact courtney smith
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/04/2011
Decision Date 08/02/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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