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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K112240
Model 32280, ETC.
Device Name DYNA LOCKING CANNULATED SCREW
Original Applicant
U&I CORP.
529-1 yonghyn-dong
uijungbu, kyunggi-do,  KS 480-050
Original Contact gyeong-je kwon
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/04/2011
Decision Date 01/04/2012
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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