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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
Applicant
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Applicant Contact J. D WEBB
Correspondent
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Correspondent 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)
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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