K211496 is an FDA 510(k) clearance for the TransLoc 3D. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Foundation Fusion Solutions, LLC (Dba Cornerloc) (Tulsa, US). The FDA issued a Cleared decision on July 27, 2022, 440 days after receiving the submission on May 13, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K211496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2021 |
| Decision Date | July 27, 2022 |
| Days to Decision | 440 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 |