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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K011354
Device Name HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
Original Applicant
DJ ORTHOPEDICS, LLC
990 park center drive, suite h
vista,  CA  92083
Original Contact jamal d rushdy
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/03/2001
Decision Date 07/31/2001
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
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