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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 K003523
Device Name DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
Applicant
DEPUY ORTHOPAEDICS, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact LYNNETTE WHITAKER
Correspondent
DEPUY ORTHOPAEDICS, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact LYNNETTE WHITAKER
Regulation Number888.3330
Classification Product Code
KWA  
Date Received11/15/2000
Decision Date 12/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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