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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 K090705
Device Name BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
Applicant
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Applicant Contact JOHANNE YOUNG
Correspondent
ORTHO DEVELOPMENT CORP.
12187 SOUTH BUSINESS PARK DR.
DRAPER,  UT  84020
Correspondent Contact JOHANNE YOUNG
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/17/2009
Decision Date 10/09/2009
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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