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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 K190230
Device Name iFuse Implant System®
Applicant
SI-BONE, Inc.
471 El Camino Real
Suite 101
Santa Clara,  CA  95050
Applicant Contact Meirav Harsat
Correspondent
Domecus Consulting Services, LLC
1171 Barroihet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number888.3040
Classification Product Code
OUR  
Date Received02/06/2019
Decision Date 04/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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