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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/Polymer, Porous Uncemented
510(k) Number K102423
Device Name DEPUY PINNACLE ALTRX ACETABULAR LINERS
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Applicant Contact BRANDON HIPSHER
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Correspondent Contact BRANDON HIPSHER
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received08/25/2010
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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