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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 cemented acetabular component)
510(k) Number K041114
Device Name PROFEMUR TAPERED HIP STEM
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Original Contact katie logerot
Regulation Number888.3320
Classification Product Code
JDL  
Subsequent Product Codes
JDI   KWA   LWJ   LZO  
Date Received04/28/2004
Decision Date 05/28/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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