K231841 is an FDA 510(k) clearance for the PathLoc SI Joint Fusion System. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on July 14, 2023, 22 days after receiving the submission on June 22, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K231841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2023 |
| Decision Date | July 14, 2023 |
| Days to Decision | 22 days |
| Submission Type | Special |
| 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 |