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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K122336
Models FG1001, FG1001A, FG1002, FG1002A
Device Name Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
Original Applicant
ELEVEN BLADE SOLUTIONS, INC.
14734 la rinconada drive
los gatos,  CA  95032
Original Contact michael kolber
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/02/2012
Decision Date 01/09/2013
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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