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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 K070554
Device Name DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
p.o box 988
warsaw,  IN  46581 0988
Original Contact kathy harris
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LZO   MEH  
Date Received03/13/2007
Decision Date 09/11/2007
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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