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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
Recalls CDRH Recalls
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