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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sacroiliac joint fixation
510(K) Number K122074
Device Name IFUSE IMPLANT SYSTEM
Applicant
SI-BONE, INC.
3055 olin ave.
suite 2200
san jose,  CA  95128
Contact cindy domecus
Regulation Number888.3040
Classification Product Code
OUR  
Date Received07/16/2012
Decision Date 10/12/2012
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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