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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 uncemented acetabular component)
510(K) Number K042992
Device Name CORAIL AMT HIP PROSTHESIS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Contact nancy s friddle
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LWJ   LZO   MEH  
Date Received11/01/2004
Decision Date 02/11/2005
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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