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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K093736
Device Name DEPUY CORAIL HIP SYSTEM, REVISION STEM
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Original Contact rhonda myer
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LWJ   MEH  
Date Received12/08/2009
Decision Date 03/10/2011
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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