K222605 is an FDA 510(k) clearance for the iFuse TORQ® Implant System. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 29, 2022, 31 days after receiving the submission on August 29, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K222605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2022 |
| Decision Date | September 29, 2022 |
| Days to Decision | 31 days |
| Submission Type | Special |
| 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 |