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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 K052614
Device Name LOW PROFILE PLATE AND SCREW SYSTEM
Original Applicant
ARTHREX, INC.
1370 creekside blvd.
naples,  FL  34108 1945
Original Contact sally foust
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/23/2005
Decision Date 09/28/2005
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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