K190025 is an FDA 510(k) clearance for the EVOL® -SI Joint Fusion System. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Cutting Edge Spine, LLC (Waxhaw, US). The FDA issued a Cleared decision on August 12, 2019, 217 days after receiving the submission on January 7, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K190025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2019 |
| Decision Date | August 12, 2019 |
| Days to Decision | 217 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 |