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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K251780
Device Name iGPS Navigation Instruments
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 Number882.4560
Classification Product Code
OLO  
Date Received06/10/2025
Decision Date 09/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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