The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Pathloc-l Mis Spinal System.
| Device ID | K183117 |
| 510k Number | K183117 |
| Device Name: | PathLoc-L 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 | 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 | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-09 |
| Decision Date | 2018-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809319759997 | K183117 | 000 |
| 08809319750420 | K183117 | 000 |
| 08809319750871 | K183117 | 000 |
| 08809319751915 | K183117 | 000 |
| 08809319752455 | K183117 | 000 |
| 08809319752790 | K183117 | 000 |
| 08809319756026 | K183117 | 000 |
| 08809319756620 | K183117 | 000 |
| 08809319758815 | K183117 | 000 |
| 08809319758969 | K183117 | 000 |
| 08809319759980 | K183117 | 000 |
| 08809319750383 | K183117 | 000 |