FDA Product Code
FDA Product Code OUR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 132 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261381 | TiLink-L SI Joint Fusion System | SurGenTec, LLC | 2026-08-24 | Traditional | PDF ↗ |
| K260477 | CATAMARAN SI Joint Fusion System | Tenon Medical | 2026-04-08 | Traditional | PDF ↗ |
| K253488 | iFuse INTRA Ti Implant System | SI-BONE, Inc. | 2026-02-11 | Traditional | PDF ↗ |
| K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 2026-01-29 | Traditional | PDF ↗ |
| K252834 | Sacroiliac Joint Truss System (SJTS) | 4Web Medical | 2026-01-28 | Traditional | PDF ↗ |
| K251365 | OptumSI Implant System | Si Solutions, LLC | 2025-11-20 | Traditional | PDF ↗ |
| K252322 | SIros-X System | Genesys Spine | 2025-10-22 | Traditional | PDF ↗ |
| K253094 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | 2025-10-09 | Special | PDF ↗ |
| K250894 | Eminent Spine Posterior SI System | Eminent Spine | 2025-10-07 | Traditional | PDF ↗ |
| K250647 | SImmetry+ System | Sivantage | 2025-07-29 | Traditional | PDF ↗ |
| K250247 | panaSIa SI Fusion System | Wenzel Spine, Inc. | 2025-07-09 | Traditional | PDF ↗ |
| K251395 | The Rialto SI Fusion System | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 | Traditional | PDF ↗ |
| K242431 | Omnia Medical PsiF DNA System | Omnia Medical, LLC | 2025-06-06 | Traditional | PDF ↗ |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC | 2025-06-06 | Special | PDF ↗ |
| K250001 | Patriot SI Implant System | Spinal Simplicity, LLC | 2025-06-03 | Traditional | PDF ↗ |
| K251075 | DYNAMIS Implant System | Promethean Restorative, LLC | 2025-04-25 | Special | PDF ↗ |
| K250403 | Catamaran SI Joint Fusion System | Tenon Medical | 2025-03-21 | Special | PDF ↗ |
| K243838 | NEXXT MATRIXX® SI System | Nexxt Spine | 2025-03-14 | Traditional | PDF ↗ |
| K243565 | DYNAMIS SI Screw System | Promethean Restorative, LLC | 2025-02-28 | Traditional | PDF ↗ |
| K243835 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-12-27 | Special | PDF ↗ |
| K242414 | TiLink-P Joint Fusion System | SurGenTec, LLC | 2024-11-21 | Traditional | PDF ↗ |
| K242141 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-08-21 | Special | PDF ↗ |
| K241504 | iFuse TORQ TNT Implant System | SI-BONE, Inc. | 2024-08-19 | Traditional | PDF ↗ |
| K241813 | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC | 2024-08-13 | Traditional | PDF ↗ |
| K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024-07-29 | Traditional | PDF ↗ |
| K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024-07-02 | Special | PDF ↗ |
| K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024-06-04 | Traditional | PDF ↗ |
| K232149 | BowTie SI Joint Fusion System | Sail Fusion, LLC | 2024-04-20 | Traditional | PDF ↗ |
| K232259 | Patriot-SI Posterior Implant System | Spinal Simplicity, LLC | 2024-04-19 | Traditional | PDF ↗ |
| K240720 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-04-11 | Special | PDF ↗ |
| K233972 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies | 2024-02-27 | Traditional | PDF ↗ |
| K240201 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2024-02-23 | Special | PDF ↗ |
| K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024-01-26 | Traditional | PDF ↗ |
| K230817 | TORPEDO Implant System® | Deltacor GmbH | 2024-01-19 | Traditional | PDF ↗ |
| K231923 | Liberty SI Lateral Implant System | Spinal Simplicity, LLC | 2023-12-05 | Traditional | PDF ↗ |
| K233241 | SOLACE Sacroiliac Fixation System | Ht Medical, LLC Dba Xenix Medical | 2023-10-27 | Special | PDF ↗ |
| K232211 | REUNION Sacroiliac Joint Fusion System | Astura Medical | 2023-10-24 | Traditional | PDF ↗ |
| K232878 | TransLoc 3D | Foundation Fusion Solutions, LLC (Dba Cornerloc) | 2023-10-17 | Special | PDF ↗ |
| K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System | Lesspine Innovations | 2023-09-28 | Special | PDF ↗ |
| K230857 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2023-09-25 | Traditional | PDF ↗ |
| K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023-09-21 | Special | PDF ↗ |
| K231944 | CATAMARAN SI Joint Fusion System | Tenon Medical, Inc. | 2023-08-24 | Traditional | PDF ↗ |
| K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | 2023-08-15 | Traditional | PDF ↗ |
| K231831 | TiLink-L Joint Fusion System | Surgentec | 2023-08-03 | Special | PDF ↗ |
| K231951 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023-07-28 | Special | PDF ↗ |
| K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2023-07-14 | Special | PDF ↗ |
| K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023-06-30 | Special | PDF ↗ |
| K230446 | TiLink-L SI Joint Fusion System | SurGenTec, LLC | 2023-06-07 | Traditional | PDF ↗ |
| K220274 | Kisar Stratford SI Screw System | Anjali Investments L.L.C | 2023-04-24 | Traditional | PDF ↗ |
| K230689 | T-FIX 3DSI Joint Fusion System | Cutting Edge Spine, LLC | 2023-04-05 | Special | PDF ↗ |
| K213815 | SiJoin®T3 | Vgi Medical, Inc. | 2023-03-29 | Traditional | PDF ↗ |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023-03-21 | Traditional | PDF ↗ |
| K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023-01-20 | Traditional | PDF ↗ |
| K223819 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | 2023-01-18 | Special | PDF ↗ |
| K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022-12-22 | Traditional | PDF ↗ |
| K211785 | CASSATT SIJ Fixation System | Ctl Medical Corporation | 2022-10-17 | Traditional | PDF ↗ |
| K222448 | UNITY Sacroiliac Joint Fixation System | Dio Medical Corporation | 2022-10-13 | Traditional | PDF ↗ |
| K221047 | SILO TFX MIS Sacroiliac Joint Fixation System | Aurora Spine, Inc. | 2022-10-03 | Traditional | PDF ↗ |
| K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022-09-29 | Special | PDF ↗ |
| K222512 | Integrity-SI Fusion System | OsteoCentric Technologies | 2022-09-12 | Special | PDF ↗ |
| K203503 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies, LLC | 2022-09-02 | Traditional | PDF ↗ |
| K211496 | TransLoc 3D | Foundation Fusion Solutions, LLC (Dba Cornerloc) | 2022-07-27 | Traditional | PDF ↗ |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System | Aegis Spine, Inc. | 2022-06-30 | Special | PDF ↗ |
| K214123 | T-FIX® 3DSI Joint Fusion System | Cutting Edge Spine, LLC | 2022-06-24 | Traditional | PDF ↗ |
| K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022-06-10 | Traditional | PDF ↗ |
| K220195 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | 2022-05-26 | Traditional | PDF ↗ |
| K212962 | TRELLIS SI Joint Fusion System | Orthofundamentals, LLC | 2022-04-11 | Traditional | PDF ↗ |
| K213590 | Blue Topaz Sacroiliac Screw System | Osseus Fusion Systems, LLC | 2022-03-01 | Traditional | PDF ↗ |
| K212903 | SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2021-12-15 | Traditional | PDF ↗ |
| K210402 | Curiteva Sacroiliac Joint Fusion System | Curiteva, Inc. | 2021-09-09 | Traditional | PDF ↗ |
| K211449 | Triton Sacroiliac Joint Fixation System | Choice Spine, LLC | 2021-08-31 | Traditional | PDF ↗ |
| K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021-03-25 | Special | PDF ↗ |
| K203780 | Harvester SI: Sacroiliac Fixation System | Spinus International, Inc. | 2021-03-23 | Traditional | PDF ↗ |
| K203247 | iFuse-TORQ Implant System | SI-BONE, Inc. | 2021-02-25 | Traditional | PDF ↗ |
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System | Aegis Spine | 2021-02-16 | Traditional | PDF ↗ |
| K203373 | Advanced Research Medical Trident SI Screw System | Advanced Research Medical, LLC | 2021-01-22 | Traditional | PDF ↗ |
| K203671 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | Medacta International S.A. | 2021-01-13 | Special | PDF ↗ |
| K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020-11-18 | Special | PDF ↗ |
| K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2020-09-18 | Traditional | PDF ↗ |
| K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020-09-15 | Traditional | PDF ↗ |
| K190580 | NADIA SI Fusion System | Ilion Medical, Inc. | 2020-08-05 | Traditional | PDF ↗ |
| K200868 | SI-Restore Sacroiliac Joint Fixation System | Biofusion Medical | 2020-04-17 | Special | PDF ↗ |
| K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020-04-02 | Special | PDF ↗ |
| K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020-03-31 | Traditional | PDF ↗ |
| K193083 | M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System | Medacta International S.A. | 2019-12-03 | Special | PDF ↗ |
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | Genesys Spine | 2019-09-26 | Traditional | PDF ↗ |
| K190025 | EVOL® -SI Joint Fusion System | Cutting Edge Spine, LLC | 2019-08-12 | Traditional | PDF ↗ |
| K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019-04-30 | Traditional | PDF ↗ |
| K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019-04-03 | Traditional | PDF ↗ |
| K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2019-02-06 | Traditional | PDF ↗ |
| K182919 | SI-Restore® Sacroiliac Joint Fixation System | Biofusion Medical | 2019-01-25 | Traditional | PDF ↗ |
| K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018-11-27 | Special | PDF ↗ |
| K181881 | Outlet Sacroiliac Joint Fusion System | Sij Surgical | 2018-10-03 | Traditional | PDF ↗ |
| K181600 | PathLoc-SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2018-07-16 | Special | PDF ↗ |
| K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2018-06-15 | Traditional | PDF ↗ |
| K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | Tenon Medical, Inc. | 2018-06-13 | Traditional | PDF ↗ |
| K173201 | UNITY Sacroiliac Joint Fixation System | Huvexel Co. , Ltd. | 2018-04-26 | Traditional | PDF ↗ |
| K173752 | SI Screw System | Zavation Medical Products, LLC | 2018-03-16 | Traditional | PDF ↗ |
| K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | Medacta International S.A. | 2017-08-02 | Traditional | PDF ↗ |
| K170475 | SICAGE System | Sicage, LLC | 2017-05-05 | Traditional | PDF ↗ |
Product code OUR · Class II · Orthopedic. Data: openFDA.