K241813 is an FDA 510(k) clearance for the SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Si-Technology, LLC (Fort Collins, US). The FDA issued a Cleared decision on August 13, 2024, 53 days after receiving the submission on June 21, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K241813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2024 |
| Decision Date | August 13, 2024 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OUR - Sacroiliac Joint Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | Sacroiliac Joint Fusion |