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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 K020383
Device Name ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
Applicant
ORTHO DEVELOPMENT CORP.
12187 S. BUSINESS PARK DR.
DRAPER,  UT  84020
Applicant Contact CAROL FREASIER
Correspondent
ORTHO DEVELOPMENT CORP.
12187 S. BUSINESS PARK DR.
DRAPER,  UT  84020
Correspondent Contact CAROL FREASIER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/05/2002
Decision Date 05/06/2002
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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