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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K122239
Models 201/202-08/09-101/112, 213/214-08/09-002/012, 233-08/09-102/112
Device Name FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING
Original Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Original Contact teffany hutto
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/27/2012
Decision Date 04/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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