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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K112108
Device Name ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
Original Applicant
SPINEART
cointrin 20 route de pre-bois
cp1813
geneva,  SZ 1215
Original Contact frank p ennesi
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received07/22/2011
Decision Date 08/19/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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