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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 K253488
Device Name iFuse INTRA Ti™ 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  
Date Received10/24/2025
Decision Date 02/11/2026
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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