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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 K040544
Device Name DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Applicant Contact DINA L WEISSMAN
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact DINA L WEISSMAN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received03/02/2004
Decision Date 05/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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