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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 K051348
Device Name CONSERVE TOTAL FEMORAL HEAD
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Applicant Contact THERESA LEISTER
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Correspondent Contact THERESA LEISTER
Regulation Number888.3320
Classification Product Code
JDL  
Subsequent Product Code
KWA  
Date Received05/24/2005
Decision Date 08/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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