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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
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