OUR — Sacroiliac Joint Fixation Class II
Classification Details
- Product Code
- OUR
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
sacroiliac joint fusion
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253488 | si-bone | iFuse INTRA Ti Implant System | February 11, 2026 |
| K253611 | mcnicoll surgical | Falco Fusion System | January 29, 2026 |
| K252834 | 4web medical | Sacroiliac Joint Truss System (SJTS) | January 28, 2026 |
| K251365 | si solutions | OptumSI Implant System | November 20, 2025 |
| K252322 | genesys spine | SIros-X System | October 22, 2025 |
| K253094 | si-bone | iFuse Bedrock Granite Implant System | October 9, 2025 |
| K250894 | eminent spine | Eminent Spine Posterior SI System | October 7, 2025 |
| K250647 | sivantage | SImmetry+ System | July 29, 2025 |
| K250247 | wenzel spine | panaSIa SI Fusion System | July 9, 2025 |
| K251395 | medtronic sofamor danek usa | The Rialto SI Fusion System | June 26, 2025 |
| K251525 | si-technology | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | June 6, 2025 |
| K242431 | omnia medical | Omnia Medical PsiF DNA System | June 6, 2025 |
| K250001 | spinal simplicity | Patriot SI Implant System | June 3, 2025 |
| K251075 | promethean restorative | DYNAMIS Implant System | April 25, 2025 |
| K250403 | tenon medical | Catamaran SI Joint Fusion System | March 21, 2025 |
| K243838 | nexxt spine | NEXXT MATRIXX® SI System | March 14, 2025 |
| K243565 | promethean restorative | DYNAMIS SI Screw System | February 28, 2025 |
| K243835 | surgentec | TiLink-P SI Joint Fusion System | December 27, 2024 |
| K242414 | surgentec | TiLink-P Joint Fusion System | November 21, 2024 |
| K242141 | surgentec | TiLink-P SI Joint Fusion System | August 21, 2024 |