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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 K102689
Device Name CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
Applicant
CONVENTUS ORTHOPAEDICS
1331 h street nw
12th floor
washington,  DC  20005
Contact hollace s rhodes
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HSB  
Date Received09/17/2010
Decision Date 01/17/2013
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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