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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 K241504
Device Name iFuse TORQ TNT™ Implant System
Applicant
Si-Bone Inc.
471 El Camino Real, Suite 101
Santa Clara,  CA  95050
Applicant Contact Jayasri Prabakaran
Correspondent
Si-Bone Inc.
471 El Camino Real, Suite 101
Santa Clara,  CA  95050
Correspondent Contact Jayasri Prabakaran
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
HWC   OLO  
Date Received05/28/2024
Decision Date 08/19/2024
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		 Yes
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