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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 K120360
Model VARIOUS
Device Name ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
Original Applicant
ORTHO SOLUTIONS LIMITED
3150 e. 200th street
prior lake,  MN  55372
Original Contact al lippincott
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC   KTT  
Date Received02/06/2012
Decision Date 05/29/2012
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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