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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 K090998
Device Name DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Original Contact rhonda myer
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   LPH   LZO  
Date Received04/08/2009
Decision Date 06/12/2009
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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