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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K122218
Device Name ADVANCE TOTAL KNEE SYSTEM-PATELLA
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Original Contact danielle mueller
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received07/25/2012
Decision Date 03/21/2013
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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