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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K262067
Device Name iFuse Granite Onyx™ 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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
OLO  
Date Received06/22/2026
Decision Date 09/23/2026
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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