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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 K081090
Device Name PROFEMUR LX 5/8 COATED HIP STEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Applicant Contact RYAN ROSS
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Correspondent Contact RYAN ROSS
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LZO   MBL  
Date Received04/16/2008
Decision Date 05/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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