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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 K060031
Device Name DEPUY MODULAR M HEADS
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
P.O. Box 988
Warsaw,  IN  46580
Applicant Contact KELI K HANKEE
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
P.O. Box 988
Warsaw,  IN  46580
Correspondent Contact KELI K HANKEE
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received01/05/2006
Decision Date 01/31/2006
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
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