The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Lnk Mis Spinal System, Pathloc-l Mis Spinal System, Accelfix-mis Spinal System.
| Device ID | K200789 |
| 510k Number | K200789 |
| Device Name: | LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | L&K BIOMED Co., Ltd. #201, #202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu Yongin-si, KR 17015 |
| Contact | Kihyang Kim |
| Correspondent | Minju Choi L&K BIOMED Co., Ltd. #201, #202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu Yongin-si, KR 17015 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-12-04 |