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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
FOIA Releasable 510(k) K062426
Device Name DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact ANNE M SCHULER
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact ANNE M SCHULER
Regulation Number888.3330
Classification Product Code
KWA  
Date Received08/18/2006
Decision Date 12/15/2006
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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