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SI-BONE, Inc. FDA Approvals

0 new drug approvals and 14 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
iFuse Granite Onyx Implant System510(k)Sep 23, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 23, 2026
iFuse INTRA Ti Implant System510(k)Feb 11, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 11, 2026
iFuse Bedrock Granite Implant System510(k)Oct 9, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 9, 2025
iGPS Navigation Instruments510(k)Sep 15, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 15, 2025
iFuse TORQ TNT Implant System510(k)Aug 19, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 19, 2024
iFuse TORQ® Implant System510(k)Jul 2, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 2, 2024
Navigation Tracking Instruments510(k)Feb 23, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2024
iFuse Bedrock Granite® Implant System510(k)Jan 26, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 26, 2024
iFuse TORQ® Implant System510(k)Jun 30, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 30, 2023
iFuse Bedrock Granite® Implant System510(k)Dec 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 22, 2022
iFuse TORQ® Implant System510(k)Sep 29, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 29, 2022
iFuse-TORQ® Implant System510(k)Jun 10, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 10, 2022
iFuse Bedrock Granite Implant System510(k)May 26, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 26, 2022
iFuse-TORQ Implant System510(k)Feb 25, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 25, 2021

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