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 | K153656 |
| 510k Number | K153656 |
| 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 446-916 |
| Contact | Yerim An |
| Correspondent | Yerim An L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si, KR 446-916 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-11-14 |
| Summary: | summary |