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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 K110029
Model VARIOUS
Device Name CONSERVE BIO FOAM SHELL
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline road
arlington,  TN  38002
Original Contact danielle mueller
Regulation Number888.3330
Classification Product Code
KWA  
Date Received01/19/2011
Decision Date 04/19/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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