Product code OUR
- Device name
- Sacroiliac Joint Fixation
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- sacroiliac joint fusion
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260477 | CATAMARAN™ SI Joint Fusion System | Tenon Medical | 2026-04-08 |
| K253488 | iFuse INTRA Ti™ Implant System | SI-BONE, Inc. | 2026-02-11 |
| K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 2026-01-29 |
| K252834 | Sacroiliac Joint Truss System (SJTS) | 4Web Medical | 2026-01-28 |
| K251365 | OptumSI Implant System | Si Solutions, LLC | 2025-11-20 |
| K252322 | SIros-X System | Genesys Spine | 2025-10-22 |
| K253094 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | 2025-10-09 |
| K250894 | Eminent Spine Posterior SI System | Eminent Spine | 2025-10-07 |
| K250647 | SImmetry+ System | Sivantage | 2025-07-29 |
| K250247 | panaSIa SI Fusion System | Wenzel Spine, Inc. | 2025-07-09 |
| K251395 | The Rialto™ SI Fusion System | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 |
| K251525 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2025-06-06 |
| K242431 | Omnia Medical PsiF DNA™ System | Omnia Medical, LLC | 2025-06-06 |
| K250001 | Patriot SI Implant System | Spinal Simplicity, LLC | 2025-06-03 |
| K251075 | DYNAMIS™ Implant System | Promethean Restorative, LLC | 2025-04-25 |
| K250403 | Catamaran SI Joint Fusion System | Tenon Medical | 2025-03-21 |
| K243838 | NEXXT MATRIXX® SI System | Nexxt Spine | 2025-03-14 |
| K243565 | DYNAMIS™ SI Screw System | Promethean Restorative, LLC | 2025-02-28 |
| K243835 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-12-27 |
| K242414 | TiLink-P Joint Fusion System | SurGenTec, LLC | 2024-11-21 |
| K242141 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-08-21 |
| K241504 | iFuse TORQ TNT™ Implant System | SI-BONE, Inc. | 2024-08-19 |
| K241813 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | Si-Technology, LLC | 2024-08-13 |
| K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024-07-29 |
| K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024-07-02 |
| K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024-06-04 |
| K232149 | BowTie™ SI Joint Fusion System | Sail Fusion, LLC | 2024-04-20 |
| K232259 | Patriot-SI Posterior Implant System | Spinal Simplicity, LLC | 2024-04-19 |
| K240720 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-04-11 |
| K233972 | Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies | 2024-02-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327075830 | ASNIS | Stryker GmbH | 2015-11-11 |
| 07613327075892 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327076035 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327076028 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327076011 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327076004 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075991 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075984 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075977 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075960 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075953 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075946 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075939 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075922 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075915 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075908 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613154158980 | NA | Stryker GmbH | 2015-09-24 |
| 07613327075885 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075878 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075861 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075854 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075847 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613327075823 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613252232735 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613252232728 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613252232711 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613252232704 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613252232698 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613252232681 | ASNIS | Stryker GmbH | 2015-09-24 |
| 07613252232674 | ASNIS | Stryker GmbH | 2015-09-24 |