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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 K121835
Device Name DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE
Original Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Original Contact michaela norris
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received06/22/2012
Decision Date 07/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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