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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
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