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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
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact RHONDA MYER
Correspondent
DePuy Synthes
3 Main Street
Ringaskiddy,  IE
Correspondent Contact Jennifer Hill
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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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