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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
Device Name Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
Applicant
ELEVEN BLADE SOLUTIONS, INC.
14734 LA RINCONADA DRIVE
LOS GATOS,  CA  95032
Applicant Contact MICHAEL KOLBER
Correspondent
ELEVEN BLADE SOLUTIONS, INC.
14734 LA RINCONADA DRIVE
LOS GATOS,  CA  95032
Correspondent Contact MICHAEL KOLBER
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/02/2012
Decision Date 01/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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