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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
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