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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 K062747
Device Name ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
Applicant
ARTHREX, INC.
1370 creekside blvd.
naples,  FL  34108 1945
Contact ann waterhouse
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
GAP   GAT  
Date Received09/14/2006
Decision Date 09/29/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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