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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 K061844
Device Name DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Original Contact matt paul
Regulation Number888.3320
Classification Product Code
JDL  
Subsequent Product Code
KWA  
Date Received06/29/2006
Decision Date 12/06/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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