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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 K060581
Device Name DEPUY SOLUTION SYSTEM HIP PROSTHESIS
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 Number888.3358
Classification Product Code
LPH  
Date Received03/07/2006
Decision Date 05/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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