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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
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Applicant Contact danielle mueller
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington,  TN  38002
Correspondent 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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