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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 K222605
Device Name iFuse TORQ® Implant System
Applicant
SI-BONE, Inc.
471 El Camino Real
Suite 101
Santa Clara,  CA  95050
Applicant Contact Meirav Harsat
Correspondent
SI-BONE, Inc.
471 El Camino Real
Suite 101
Santa Clara,  CA  95050
Correspondent Contact Meirav Harsat
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
HWC   OLO  
Date Received08/29/2022
Decision Date 09/29/2022
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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