K253094 is an FDA 510(k) clearance for the iFuse Bedrock Granite 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 October 9, 2025, 16 days after receiving the submission on September 23, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K253094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2025 |
| Decision Date | October 09, 2025 |
| Days to Decision | 16 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 |