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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 K121672
Model S002-3000, SO02-3001, SO02-3002, SO02-3003
Device Name AFT PROXIMAL HUMERUS FRACTURE PLATE
Original Applicant
SHOULDER OPTIONS, INC.
100 e. south main st.
p.o. box 1458
waxhaw,  NC  28173
Original Contact john kapitan
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/06/2012
Decision Date 10/01/2012
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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