K110472 is an FDA 510(k) clearance for the SI-FIX SACROILIAC JOINT FUSION SYSTEM. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on May 29, 2012, 466 days after receiving the submission on February 18, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K110472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2011 |
| Decision Date | May 29, 2012 |
| Days to Decision | 466 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 |