OUR — Sacroiliac Joint Fixation Class II
FDA product code OUR covers "Sacroiliac Joint Fixation", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260477 | tenon medical | CATAMARAN SI Joint Fusion System | April 8, 2026 |
| 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 |