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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 K090492
Device Name 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Original Contact suzana otano
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/25/2009
Decision Date 03/31/2009
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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