The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Pathloc-si Joint Fusion System.
| Device ID | K181600 |
| 510k Number | K181600 |
| Device Name: | PathLoc-SI Joint Fusion System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si, KR 17015 |
| Contact | Jihyeon Seo |
| Correspondent | Jihyeon Seo L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si, KR 17015 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-18 |
| Decision Date | 2018-07-16 |
| Summary: | summary |