Panels › Orthopedic › Product code OUR · Class 2
Sacroiliac Joint Fixation
Regulation 888.3040
7510(k)s in 12 months (133 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OUR
| Company | 510(k)s | Recalls |
|---|---|---|
| SI-BONE, Inc. | 27 | 1 |
| SurGenTec, LLC | 8 | 0 |
| Zyga Technology, Inc. | 6 | 0 |
| Life Spine, Inc. | 5 | 0 |
| Orthofix, Inc. | 5 | 0 |
| L&K BIOMED Co., Ltd. | 4 | 0 |
| Tenon Medical | 4 | 0 |
| Aegis Spine | 3 | 0 |
| Camber Spine Technologies | 3 | 0 |
| Cutting Edge Spine, LLC | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 5, 2023 | K230689 | T-FIX 3DSI Joint Fusion System Cutting Edge Spine, LLC | OUR |
| Mar 29, 2023 | K213815 | SiJoin®T3 Vgi Medical, Inc. | OUR |
| Mar 21, 2023 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System Corelink, LLC | OUR |
| Jan 20, 2023 | K223521 | ZESPIN SI Joint Fusion System Aegis Spine, Inc. | OUR |
| Jan 18, 2023 | K223819 | SI-Cure Sacroiliac Joint Fusion System Alevio, LLC | OUR |
| Dec 22, 2022 | K222774 | iFuse Bedrock Granite® Implant System SI-BONE, Inc. | OUR |
| Oct 17, 2022 | K211785 | CASSATT SIJ Fixation System Ctl Medical Corporation | OUR |
| Oct 13, 2022 | K222448 | UNITY Sacroiliac Joint Fixation System Dio Medical Corporation | OUR |
| Oct 3, 2022 | K221047 | SILO TFX MIS Sacroiliac Joint Fixation System Aurora Spine, Inc. | OUR |
| Sep 29, 2022 | K222605 | iFuse TORQ® Implant System SI-BONE, Inc. | OUR |
| Sep 12, 2022 | K222512 | Integrity-SI Fusion System OsteoCentric Technologies | OUR |
| Sep 2, 2022 | K203503 | Camber Sacroiliac (SI) Fixation System Camber Spine Technologies, LLC | OUR |
| Jul 27, 2022 | K211496 | TransLoc 3D Foundation Fusion Solutions, LLC (Dba Cornerloc) | OUR |
| Jun 30, 2022 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema L Aegis Spine, Inc. | OUR |
| Jun 24, 2022 | K214123 | T-FIX® 3DSI Joint Fusion System Cutting Edge Spine, LLC | OUR |
| Jun 10, 2022 | K213667 | iFuse-TORQ® Implant System SI-BONE, Inc. | OUR |
| May 26, 2022 | K220195 | iFuse Bedrock Granite Implant System SI-BONE, Inc. | OUR |
| Apr 11, 2022 | K212962 | TRELLIS SI Joint Fusion System Orthofundamentals, LLC | OUR |
| Mar 1, 2022 | K213590 | Blue Topaz Sacroiliac Screw System Osseus Fusion Systems, LLC | OUR |
| Dec 15, 2021 | K212903 | SIMPACT Sacroiliac Joint Fixation System Life Spine, Inc. | OUR |
| Sep 9, 2021 | K210402 | Curiteva Sacroiliac Joint Fusion System Curiteva, Inc. | OUR |
| Aug 31, 2021 | K211449 | Triton Sacroiliac Joint Fixation System Choice Spine, LLC | OUR |
| Mar 25, 2021 | K210667 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Mar 23, 2021 | K203780 | Harvester SI: Sacroiliac Fixation System Spinus International, Inc. | OUR |
| Feb 25, 2021 | K203247 | iFuse-TORQ Implant System SI-BONE, Inc. | OUR |
| Feb 16, 2021 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Aegis Spine | OUR |
| Jan 22, 2021 | K203373 | Advanced Research Medical Trident SI Screw System Advanced Research Medical, LLC | OUR |
| Jan 13, 2021 | K203671 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System Medacta International S.A., CH | OUR |
| Nov 18, 2020 | K203138 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Sep 18, 2020 | K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System Life Spine, Inc. | OUR |
| Sep 15, 2020 | K201664 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Aug 5, 2020 | K190580 | NADIA SI Fusion System Ilion Medical, Inc. | OUR |
| Apr 17, 2020 | K200868 | SI-Restore Sacroiliac Joint Fixation System Biofusion Medical | OUR |
| Apr 2, 2020 | K200696 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Mar 31, 2020 | K193524 | SI-BONE iFuse Implant System® SI-BONE, Inc. | OUR |
| Dec 3, 2019 | K193083 | M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System Medacta International S.A., CH | OUR |
| Sep 26, 2019 | K191748 | Genesys Spine Sacroiliac Joint Fusion System Genesys Spine | OUR |
| Aug 12, 2019 | K190025 | EVOL® -SI Joint Fusion System Cutting Edge Spine, LLC | OUR |
| Apr 30, 2019 | K183342 | SambaScrew 3D SI Fusion System Orthofix, Inc. | OUR |
| Apr 3, 2019 | K190230 | iFuse Implant System® SI-BONE, Inc. | OUR |
| Feb 6, 2019 | K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments Globus Medical, Inc. | OUR |
| Jan 25, 2019 | K182919 | SI-Restore® Sacroiliac Joint Fixation System Biofusion Medical | OUR |
| Nov 27, 2018 | K182983 | iFuse Implant System® SI-BONE, Inc. | OUR |
| Oct 3, 2018 | K181881 | Outlet Sacroiliac Joint Fusion System Sij Surgical | OUR |
| Jul 16, 2018 | K181600 | PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd., KR | OUR |
| Jun 15, 2018 | K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System Life Spine, Inc. | OUR |
| Jun 13, 2018 | K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) Tenon Medical, Inc. | OUR |
| Apr 26, 2018 | K173201 | UNITY Sacroiliac Joint Fixation System Huvexel Co. , Ltd., KR | OUR |
| Mar 16, 2018 | K173752 | SI Screw System Zavation Medical Products, LLC | OUR |
| Aug 2, 2017 | K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System Medacta International S.A., CH | OUR |
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