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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 K021349
Device Name METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Original Contact ehab m esmail
Regulation Number888.3330
Classification Product Code
KWA  
Date Received04/29/2002
Decision Date 07/01/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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