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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 K020114
Device Name 3D KNEE
Original Applicant
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin,  TX  78758
Original Contact joanna droege
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/11/2002
Decision Date 07/12/2002
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
Recalls CDRH Recalls
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