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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, constrained, cemented or uncemented, metal/polymer
510(k) Number K071117
Device Name MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46582
Applicant Contact Natalie Heck
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46582
Correspondent Contact Natalie Heck
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received04/20/2007
Decision Date 05/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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