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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 K111663
Device Name TRAUMA INTERNAL FIXATION SYSTEMS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Original Contact suzana otano
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HSB   HTN   HTY   HWC   JDW  
KTT   LXT  
Date Received06/14/2011
Decision Date 03/12/2012
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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