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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 K062426
Device Name DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
p.o box 988
warsaw,  IN  46581 0988
Original Contact anne m schuler
Regulation Number888.3330
Classification Product Code
KWA  
Date Received09/01/2006
Decision Date 12/15/2006
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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