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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 K193524
Device Name SI-BONE iFuse Implant System®
Applicant
SI-BONE, Inc.
47 El Camino Real, Suite 101
Santa Clara,  CA  95050
Applicant Contact Susan Noriega
Correspondent
SI-BONE, Inc.
47 El Camino Real, Suite 101
Santa Clara,  CA  95050
Correspondent Contact Susan Noriega
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
LXH  
Date Received12/19/2019
Decision Date 03/31/2020
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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