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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 uncemented acetabular component)
510(k) Number K082239
Device Name DEPUY C-STEM AMT
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46582
Applicant Contact RHONDA MYER
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46582
Correspondent Contact RHONDA MYER
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   LPH   LZO  
Date Received08/07/2008
Decision Date 08/29/2008
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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