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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 K253094
Device Name iFuse Bedrock Granite Implant System
Applicant
SI-BONE, Inc.
471 El Camino Real, Suite 101
Santa Clara,  CA  95070
Applicant Contact Jayasri Prabakaran
Correspondent
SI-BONE, Inc.
471 El Camino Real, Suite 101
Santa Clara,  CA  95070
Correspondent Contact Jayasri Prabakaran
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
NKB   OLO  
Date Received09/23/2025
Decision Date 10/09/2025
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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