ClearanceBrief
Company · US

SI-BONE, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.

33510(k) clearances (2 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
OURSacroiliac Joint Fixation28
OLOOrthopedic Stereotaxic Instrument4
NKBThoracolumbosacral Pedicle Screw System1
PDQNeurosurgical Nerve Locator1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 23, 2026K262067iFuse Granite Onyx™ Implant System
SI-BONE, Inc.
NKB
Feb 11, 2026K253488iFuse INTRA Ti™ Implant System
SI-BONE, Inc.
OUR
Oct 9, 2025K253094iFuse Bedrock Granite Implant System
SI-BONE, Inc.
OUR
Sep 15, 2025K251780iGPS Navigation Instruments
SI-BONE, Inc.
OLO
Aug 19, 2024K241504iFuse TORQ TNT™ Implant System
SI-BONE, Inc.
OUR
Jul 2, 2024K241574iFuse TORQ® Implant System
SI-BONE, Inc.
OUR
Feb 23, 2024K232800Navigation Tracking Instruments
SI-BONE, Inc.
OLO
Jan 26, 2024K233508iFuse Bedrock Granite® Implant System
SI-BONE, Inc.
OUR
Jun 30, 2023K231689iFuse TORQ® Implant System
SI-BONE, Inc.
OUR
Dec 22, 2022K222774iFuse Bedrock Granite® Implant System
SI-BONE, Inc.
OUR
Sep 29, 2022K222605iFuse TORQ® Implant System
SI-BONE, Inc.
OUR
Jun 10, 2022K213667iFuse-TORQ® Implant System
SI-BONE, Inc.
OUR
May 26, 2022K220195iFuse Bedrock Granite™ Implant System
SI-BONE, Inc.
OUR
Feb 25, 2021K203247iFuse-TORQ™ Implant System
SI-BONE, Inc.
OUR
Nov 9, 2020K203110iFuse Implant System - iFuse Navigation
SI-BONE, Inc.
OLO
Mar 31, 2020K193524SI-BONE iFuse Implant System®
SI-BONE, Inc.
OUR
Apr 3, 2019K190230iFuse Implant System®
SI-BONE, Inc.
OUR
Nov 27, 2018K182983iFuse Implant System®
SI-BONE, Inc.
OUR
Oct 31, 2017K172268iFuse Implant System- iFuse Navigation
SI-BONE, Inc.
OLO
Mar 10, 2017K162733iFuse Implant System® - iFuse-3D implant
SI-BONE, Inc.
OUR
Oct 18, 2016K161893Neuromonitoring Kit
SI-BONE, Inc.
PDQ
Jun 3, 2016K160652iFUSE Implant System
SI-BONE, Inc.
OUR
Mar 1, 2016K152681iFuse Implant System(R)
SI-BONE, Inc.
OUR
Oct 29, 2015K151718iFuse Implant System
SI-BONE, Inc.
OUR
Jul 22, 2015K150875iFuse Implant System
SI-BONE, Inc.
OUR
Apr 17, 2015K150714SI-BONE iFuse Implant System
SI-BONE, Inc.
OUR
Jul 23, 2014K141049IFUSE IMPLANT SYSTEM
SI-BONE, Inc.
OUR
Oct 16, 2013K131405IFUSE IMPLANT SYSTEM
SI-BONE, Inc.
OUR
Apr 1, 2013K123850IFUSE IMPLANT SYSTEM
SI-BONE, Inc.
OUR
Oct 12, 2012K122074IFUSE IMPLANT SYSTEM
SI-BONE, Inc.
OUR
Apr 21, 2011K110838IFUSE IMPLANT SYSTEM
SI-BONE, Inc.
OUR
Sep 4, 2009K092375MODIFICATION TO SI JOINT FUSION SYSTEM
SI-BONE, Inc.
OUR
Nov 26, 2008K080398SI JOINT FUSION SYSTEM
SI-BONE, Inc.
OUR

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 9, 2026SI-BONE, Inc.
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Open, Classified		 OURK203247
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