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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 K111698
Device Name PROFEMUR(R) E CEMENTLESS HIP STEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
arlington,  TN  38002
Applicant Contact gregory neal
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
arlington,  TN  38002
Correspondent Contact gregory neal
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDL   LPH   LZO  
Date Received06/17/2011
Decision Date 08/19/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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