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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 K172268
Device Name iFuse Implant System- iFuse Navigation
Applicant
SI-BONE, Inc.
3055 Olin Ave., Suite 2200
San Jose,  CA  95128
Applicant Contact Roxanne Dubois
Correspondent
SI-BONE, Inc.
3055 Olin Ave., Suite 2200
San Jose,  CA  95128
Correspondent Contact Roxanne Dubois
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/27/2017
Decision Date 10/31/2017
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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