K123850 is an FDA 510(k) clearance for the IFUSE IMPLANT SYSTEM. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by SI-BONE, Inc. (Hillsborough, US). The FDA issued a Cleared decision on April 1, 2013, 108 days after receiving the submission on December 14, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K123850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2012 |
| Decision Date | April 01, 2013 |
| Days to Decision | 108 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 |