FDA 510(k) Applications for Medical Device Product Code "OUR"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K203373 | Advanced Research Medical, LLC | Advanced Research Medical Trident SI Screw System | 01/22/2021 |
| K210035 | Aegis Spine | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System | 02/16/2021 |
| K223521 | Aegis Spine, Inc. | ZESPIN SI Joint Fusion System | 01/20/2023 |
| K221050 | Aegis Spine, Inc. | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System | 06/30/2022 |
| K231951 | Alevio, LLC | SI-Cure Sacroiliac Joint Fusion System | 07/28/2023 |
| K223819 | Alevio, LLC | SI-Cure Sacroiliac Joint Fusion System | 01/18/2023 |
| K220274 | Anjali Investments L.L.C | Kisar Stratford SI Screw System | 04/24/2023 |
| K232211 | Astura Medical | REUNION Sacroiliac Joint Fusion System | 10/24/2023 |
| K221047 | Aurora Spine, Inc. | SILO TFX MIS Sacroiliac Joint Fixation System | 10/03/2022 |
| K200868 | Biofusion Medical | SI-Restore Sacroiliac Joint Fixation System | 04/17/2020 |
| K182919 | Biofusion Medical | SI-Restore« Sacroiliac Joint Fixation System | 01/25/2019 |
| K233972 | Camber Spine Technologies | Camber Sacroiliac (SI) Fixation System | 02/27/2024 |
| K162121 | CAMBER SPINE TECHNOLOGIES | Siconus SI Joint Fixation System | 01/18/2017 |
| K203503 | Camber Spine Technologies, LLC | Camber Sacroiliac (SI) Fixation System | 09/02/2022 |
| K211449 | ChoiceSpine, LLC | TritonÖ Sacroiliac Joint Fixation System | 08/31/2021 |
| K161755 | CoorsTek Medical | Integrity-SI TM Fusion System | 12/14/2016 |
| K223708 | CoreLink, LLC | Entasis 3D Dual-Lead Sacroiliac Implant System | 03/21/2023 |
| K152237 | CoreLink, LLC | The Entasis Dual-Lead Sacroiliac Implant | 02/04/2016 |
| K211785 | CTL Medical Corporation | CASSATTÖ SIJ Fixation System | 10/17/2022 |
| K210402 | Curiteva, Inc. | Curiteva Sacroiliac Joint Fusion System | 09/09/2021 |
| K190025 | Cutting Edge Spine, LLC | EVOL« -SI Joint Fusion System | 08/12/2019 |
| K214123 | Cutting Edge Spine, LLC | T-FIX« 3DSI Joint Fusion System | 06/24/2022 |
| K230689 | Cutting Edge Spine, LLC | T-FIXÖ 3DSI Joint Fusion System | 04/05/2023 |
| K230817 | Deltacor GmbH | TORPEDO Implant System« | 01/19/2024 |
| K051296 | DEPUY SPINE, INC. | SIJF CANNULATED SCREW SYSTEM | 08/26/2005 |
| K222448 | Dio Medical Corporation | UNITY Sacroiliac Joint Fixation System | 10/13/2022 |
| K240505 | Eminent Spine, LLC | Eminent Spine SI Screw System | 06/04/2024 |
| K141106 | FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES | FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM | 10/10/2014 |
| K211496 | Foundation Fusion Solutions, LLC (dba CornerLoc) | TransLoc 3D | 07/27/2022 |
| K232878 | Foundation Fusion Solutions, LLC (dba CornerLoc) | TransLoc 3D | 10/17/2023 |
| K191748 | Genesys Spine | Genesys Spine Sacroiliac Joint Fusion System | 09/26/2019 |
| K183119 | Globus Medical Inc. | SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments | 02/06/2019 |
| K231829 | HT Medical d.b.a. Xenix Medical | Xenix Medical Sacroiliac Fixation System | 08/15/2023 |
| K233241 | HT Medical LLC dba Xenix Medical | SOLACE Sacroiliac Fixation System | 10/27/2023 |
| K173201 | Huvexel Co., Ltd | UNITY Sacroiliac Joint Fixation System | 04/26/2018 |
| K190580 | Ilion Medical Inc | NADIA SI Fusion System | 08/05/2020 |
| K231841 | L & K Biomed Co., Ltd. | PathLoc SI Joint Fusion System | 07/14/2023 |
| K240201 | L&K Biomed Co., Ltd. | PathLoc SI Joint Fusion System | 02/23/2024 |
| K153656 | L&K BIOMED Co., Ltd. | PathLoc-SI Joint Fusion System | 11/14/2016 |
| K181600 | L&K BIOMED Co., Ltd. | PathLoc-SI Joint Fusion System | 07/16/2018 |
| K232605 | LESspine Innovations | Sacrix« Sacroiliac Joint Fusion Device System, Inspan« ScrewLES Fusion System, Invue« MAXÖ + Invue Inset Anterior Cervical Plate System, and FacetFuse« Screw Fixation System | 09/28/2023 |
| K180749 | Life Spine Inc. | Life Spine SIMPACT Sacroiliac Joint Fixation System | 06/15/2018 |
| K201538 | Life Spine Inc. | Life Spine SIMPACT Sacroiliac Joint Fixation System | 09/18/2020 |
| K141246 | LIFE SPINE, INC | LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM | 02/22/2015 |
| K241464 | Life Spine, Inc. | ARx« SAI Implant System | 07/29/2024 |
| K212903 | Life Spine, Inc. | SIMPACT Sacroiliac Joint Fixation System | 12/15/2021 |
| K171595 | Medacta International SA | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | 08/02/2017 |
| K203671 | Medacta International SA | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | 01/13/2021 |
| K193083 | Medacta International SA | M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System | 12/03/2019 |
| K161210 | Medtronic Sofamor Danek | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | 08/12/2016 |
| K110472 | MEDTRONIC SOFAMOR DANEK | SI-FIX SACROILIAC JOINT FUSION SYSTEM | 05/29/2012 |
| K251395 | Medtronic Sofamor Danek USA, Inc. | The RialtoÖ SI Fusion System | 06/26/2025 |
| K243838 | Nexxt Spine | NEXXT MATRIXX« SI System | 03/14/2025 |
| K242431 | Omnia Medical, LLC | Omnia Medical PsiF DNAÖ System | 06/06/2025 |
| K200696 | Orthofix Inc. | FIREBIRD SI Fusion System | 04/02/2020 |
| K201664 | Orthofix Inc. | FIREBIRD SI Fusion System | 09/15/2020 |
| K203138 | Orthofix Inc. | FIREBIRD SI Fusion System | 11/18/2020 |
| K210667 | Orthofix Inc. | FIREBIRD SI Fusion System | 03/25/2021 |
| K183342 | Orthofix Inc. | SambaScrew 3D SI Fusion System | 04/30/2019 |
| K212962 | OrthoFundamentals, LLC | TRELLISÖ SI Joint Fusion System | 04/11/2022 |
| K213590 | Osseus Fusion Systems, LLC | Blue Topaz Sacroiliac Screw System | 03/01/2022 |
| K222512 | OsteoCentric Technologies | Integrity-SI Fusion System | 09/12/2022 |
| K230226 | OsteoCentric Technologies | Integrity-SI« Fusion System | 09/21/2023 |
| K251075 | Promethean Restorative LLC | DYNAMISÖ Implant System | 04/25/2025 |
| K243565 | Promethean Restorative LLC | DYNAMISÖ SI Screw System | 02/28/2025 |
| K232149 | SAIL Fusion, LLC | BowTieÖ SI Joint Fusion System | 04/20/2024 |
| K241504 | Si-Bone Inc. | iFuse TORQ TNTÖ Implant System | 08/19/2024 |
| K241574 | SI-BONE Inc. | iFuse TORQ« Implant System | 07/02/2024 |
| K193524 | Si-Bone, Inc | SI-BONE iFuse Implant System« | 03/31/2020 |
| K222774 | SI-BONE, Inc. | iFuse Bedrock Granite« Implant System | 12/22/2022 |
| K233508 | Si-Bone, Inc. | iFuse Bedrock Granite« Implant System | 01/26/2024 |
| K220195 | SI-BONE, Inc. | iFuse Bedrock GraniteÖ Implant System | 05/26/2022 |
| K123850 | SI-BONE, INC. | IFUSE IMPLANT SYSTEM | 04/01/2013 |
| K131405 | SI-BONE, INC. | IFUSE IMPLANT SYSTEM | 10/16/2013 |
| K110838 | SI-BONE, INC. | IFUSE IMPLANT SYSTEM | 04/21/2011 |
| K141049 | SI-BONE, INC. | IFUSE IMPLANT SYSTEM | 07/23/2014 |
| K122074 | SI-BONE, INC. | IFUSE IMPLANT SYSTEM | 10/12/2012 |
| K160652 | SI-BONE, INC. | iFUSE Implant System | 06/03/2016 |
| K150875 | SI-BONE, Inc. | iFuse Implant System | 07/22/2015 |
| K151718 | SI-BONE, INC. | iFuse Implant System | 10/29/2015 |
| K182983 | SI-BONE, Inc. | iFuse Implant System« | 11/27/2018 |
| K190230 | SI-BONE, Inc. | iFuse Implant System« | 04/03/2019 |
| K162733 | SI-BONE, INC. | iFuse Implant System« - iFuse-3D implant | 03/10/2017 |
| K152681 | SI-BONE, INC. | iFuse Implant System(R) | 03/01/2016 |
| K231689 | Si-Bone, Inc. | iFuse TORQ« Implant System | 06/30/2023 |
| K222605 | SI-BONE, Inc. | iFuse TORQ« Implant System | 09/29/2022 |
| K213667 | SI-BONE, Inc. | iFuse-TORQ« Implant System | 06/10/2022 |
| K203247 | SI-BONE, Inc. | iFuse-TORQÖ Implant System | 02/25/2021 |
| K092375 | SI-BONE, INC. | MODIFICATION TO SI JOINT FUSION SYSTEM | 09/04/2009 |
| K080398 | SI-BONE, INC. | SI JOINT FUSION SYSTEM | 11/26/2008 |
| K150714 | SI-BONE, Inc. | SI-BONE iFuse Implant System | 04/17/2015 |
| K151462 | SI-TECHNOLOGY, LLC | SI-TECHNOLOGY« SI-DESIS« SCREWS | 08/12/2015 |
| K241813 | SI-Technology, LLC | SI-TECHNOLOGY« SI-DESIS« XÖ Sacroiliac Joint Fusion System | 08/13/2024 |
| K251525 | SI-Technology, LLC | SI-TECHNOLOGY« SI-DESIS« XÖ Sacroiliac Joint Fusion System | 06/06/2025 |
| K170475 | Sicage LLc | SICAGEÖ System | 05/05/2017 |
| K181881 | SIJ Surgical | Outlet Sacroiliac Joint Fusion System | 10/03/2018 |
| K231923 | Spinal Simplicity LLC | Liberty SI Lateral Implant System | 12/05/2023 |
| K250001 | Spinal Simplicity LLC | Patriot SI Implant System | 06/03/2025 |
| K232259 | Spinal Simplicity LLC | Patriot-SI Posterior Implant System | 04/19/2024 |
| K150017 | SpineFrontier, Inc. | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | 04/24/2015 |
| K203780 | Spinus International, Inc. | Harvester SI: Sacroiliac Fixation System | 03/23/2021 |
| K231831 | SurGenTec | TiLink-L Joint Fusion System | 08/03/2023 |
| K242414 | SurGenTec LLC | TiLink-P Joint Fusion System | 11/21/2024 |
| K243835 | SurGenTec LLC | TiLink-P SI Joint Fusion System | 12/27/2024 |
| K230446 | Surgentec, LLC | TiLink-L SI Joint Fusion System | 06/07/2023 |
| K230857 | Surgentec, LLC | TiLink-P SI Joint Fusion System | 09/25/2023 |
| K240720 | SurGenTec, LLC | TiLink-P SI Joint Fusion System | 04/11/2024 |
| K242141 | SurGenTec, LLC | TiLink-P SI Joint Fusion System | 08/21/2024 |
| K250403 | Tenon Medical | Catamaran SI Joint Fusion System | 03/21/2025 |
| K180818 | Tenon Medical, Inc. | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | 06/13/2018 |
| K231944 | Tenon Medical, Inc. | CATAMARAN SI Joint Fusion System | 08/24/2023 |
| K213815 | VGI Medical, Inc. | SiJoin«T3 | 03/29/2023 |
| K250247 | Wenzel Spine, Inc. | panaSIa SI Fusion System | 07/09/2025 |
| K140079 | X-SPINE SYSTEMS, INC | SILEX SACROILIAC JOINT FUSION SYSTEM | 03/25/2014 |
| K123702 | X-SPINE SYSTEMS, INC. | SILEX SACROILIAC JOINT FUSION SYSTEM | 03/11/2013 |
| K173752 | Zavation Medical Products, LLC | SI Screw System | 03/16/2018 |
| K141549 | Zyga Technology, Inc. | SImmetry Sacroiliac Joint Fusion System | 01/15/2015 |
| K151818 | Zyga Technology, Inc. | SImmetry Sacroiliac Joint Fusion System | 08/05/2015 |
| K130092 | Zyga Technology, Inc. | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | 02/27/2013 |
| K102907 | Zyga Technology, Inc. | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | 12/14/2010 |
| K110512 | Zyga Technology, Inc. | SIMMETRY SACROILIAC JOINT FUSION SYSTEM | 03/23/2011 |
| K111801 | Zyga Technology, Inc. | SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM | 07/21/2011 |
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