K211449 is an FDA 510(k) clearance for the Triton™ Sacroiliac Joint Fixation System. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Choice Spine, LLC (Knoxville, US). The FDA issued a Cleared decision on August 31, 2021, 113 days after receiving the submission on May 10, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K211449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2021 |
| Decision Date | August 31, 2021 |
| Days to Decision | 113 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 |