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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 K060356
Device Name CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Original Contact matt paul
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Code
JDL  
Date Received02/13/2006
Decision Date 04/18/2006
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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