The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Pathloc Lumbar Interbody Fusion Cage System.
| Device ID | K213441 |
| 510k Number | K213441 |
| Device Name: | PathLoc Lumbar Interbody Fusion Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | L&K BioMed Co., Ltd. #101, 201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu, Yongin-si, KR 17015 |
| Contact | Kang-keun Lee |
| Correspondent | Kang-keun Lee L&K BioMed Co., Ltd. #101, 201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu, Yongin-si, KR 17015 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-25 |
| Decision Date | 2022-03-09 |