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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 K152169
Device Name Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
Applicant
ORTHO DEVELOPMENT CORPORATION
12187 SOUTH BUSINESS PARK DRIVE
DRAPER,  UT  84020
Applicant Contact DREW WEAVER
Correspondent
ORTHO DEVELOPMENT CORPORATION
12187 SOUTH BUSINESS PARK DRIVE
DRAPER,  UT  84020
Correspondent Contact DREW WEAVER
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received08/04/2015
Decision Date 10/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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