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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