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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 K121148
Model 11-1109-FD1, 11-1109-FD2, 11-1109-FD3, 11-1109-FD4, 11-1109-FD5, 11-1109-FD6
Device Name SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
Original Applicant
MEDICAL DESIGN LLC.
6709 s. minnesota ave. ste 204
sioux falls,  SD  57108 2593
Original Contact kristi vondra
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
OUR  
Date Received04/16/2012
Decision Date 08/20/2012
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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