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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 K123850
Device Name IFUSE IMPLANT SYSTEM
Applicant
SI-BONE, Inc.
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Applicant Contact CINDY DOMECUS
Correspondent
SI-BONE, Inc.
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact CINDY DOMECUS
Regulation Number888.3040
Classification Product Code
OUR  
Date Received12/14/2012
Decision Date 04/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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