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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 K000636
Device Name STRYKER TRAUMA PLATING SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale,  NJ  07401 1677
Original Contact mary-catherine dillon
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/25/2000
Decision Date 05/11/2000
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
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