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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 K070785
Device Name DYNASTY ACETABULAR SYSTEM
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 Number888.3320
Classification Product Code
JDL  
Subsequent Product Codes
JDI   KWA   LPH   MBL  
Date Received03/21/2007
Decision Date 07/11/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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