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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 K994370
Device Name ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
Original Applicant
ORTHO DEVELOPMENT CORP.
106 west 12200 south
draper,  UT  84020
Original Contact carol freasier
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/27/1999
Decision Date 03/24/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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