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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 K060358
Device Name PROFEMUR TL HIP STEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Applicant Contact matt paul
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Correspodent Contact matt paul
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   LWJ   LZO  
Date Received02/13/2006
Decision Date 05/10/2006
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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