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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 K923277
Device Name FOUNDATION KNEE SYSTEM
Applicant
ENCORE ORTHOPEDICS, INC.
P.O. BOX 33
RED ROCK,  TX  78662
Applicant Contact WEBB
Correspondent
ENCORE ORTHOPEDICS, INC.
P.O. BOX 33
RED ROCK,  TX  78662
Correspondent Contact WEBB
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/06/1992
Decision Date 02/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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