K213815 is an FDA 510(k) clearance for the SiJoin®T3. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Vgi Medical, Inc. (Largo, US). The FDA issued a Cleared decision on March 29, 2023, 477 days after receiving the submission on December 7, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K213815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2021 |
| Decision Date | March 29, 2023 |
| Days to Decision | 477 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 |