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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 K102565
Device Name ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
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
JDI   JDL   LWJ   LZO  
Date Received09/07/2010
Decision Date 12/22/2010
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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