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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 K932425
Device Name FOUNDATION MODULAR TIBIAL BASEPLATE
Original Applicant
ENCORE ORTHOPEDICS, INC.
8920 business park dr.
sutie 380
austin,  TX  78759
Original Contact j. d webb
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/19/1993
Decision Date 07/22/1994
Decision substantially equivalent for some indications (SN)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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