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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 K203110
Device Name iFuse Implant System - iFuse Navigation
Applicant
SI-BONE, Inc.
471 El Camino Real
Suite 101
Santa Clara,  CA  95050
Applicant Contact Nancy Kaiser
Correspondent
SI-BONE, Inc.
471 El Camino Real
Suite 101
Santa Clara,  CA  95050
Correspondent Contact Nancy Kaiser
Regulation Number882.4560
Classification Product Code
OLO  
Date Received10/15/2020
Decision Date 11/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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