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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 K970031
Device Name FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
Original Applicant
ENCORE ORTHOPEDICS, INC.
8900 shoal creek blvd.,
bldg. 300
austin,  TX  78757
Original Contact ashley m bock
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/03/1997
Decision Date 04/02/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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