K153656 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. (Giheung-Gu, Yongin-Si, KR). The FDA issued a Cleared decision on November 14, 2016, 329 days after receiving the submission on December 21, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K153656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2015 |
| Decision Date | November 14, 2016 |
| Days to Decision | 329 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 |