FDA 510(k) Applications Submitted by SI-BONE, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K131405 05/15/2013 IFUSE IMPLANT SYSTEM SI-BONE, INC.
K122074 07/16/2012 IFUSE IMPLANT SYSTEM SI-BONE, INC.
K123850 12/14/2012 IFUSE IMPLANT SYSTEM SI-BONE, INC.
K092375 08/05/2009 MODIFICATION TO SI JOINT FUSION SYSTEM SI-BONE, INC.
K110838 03/25/2011 IFUSE IMPLANT SYSTEM SI-BONE, INC.
K080398 02/13/2008 SI JOINT FUSION SYSTEM SI-BONE, INC.
K220195 01/24/2022 iFuse Bedrock GraniteÖ Implant System SI-BONE, Inc.
K190230 02/06/2019 iFuse Implant System« SI-BONE, Inc.
K231689 06/09/2023 iFuse TORQ« Implant System Si-Bone, Inc.
K222605 08/29/2022 iFuse TORQ« Implant System SI-BONE, Inc.
K222774 09/14/2022 iFuse Bedrock Granite« Implant System SI-BONE, Inc.
K213667 11/22/2021 iFuse-TORQ« Implant System SI-BONE, Inc.
K203110 10/15/2020 iFuse Implant System - iFuse Navigation SI-BONE, Inc.
K160652 03/08/2016 iFUSE Implant System SI-BONE, INC.
K150714 03/19/2015 SI-BONE iFuse Implant System SI-BONE, Inc.
K150875 04/01/2015 iFuse Implant System SI-BONE, Inc.
K141049 04/23/2014 IFUSE IMPLANT SYSTEM SI-BONE, INC.
K151718 06/25/2015 iFuse Implant System SI-BONE, INC.
K161893 07/11/2016 Neuromonitoring Kit SI-BONE, INC.
K172268 07/27/2017 iFuse Implant System- iFuse Navigation SI-BONE, Inc.
K152681 09/18/2015 iFuse Implant System(R) SI-BONE, INC.
K162733 09/29/2016 iFuse Implant System« - iFuse-3D implant SI-BONE, INC.
K182983 10/29/2018 iFuse Implant System« SI-BONE, Inc.
K203247 11/04/2020 iFuse-TORQÖ Implant System SI-BONE, Inc.


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