The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Lnk Spinal Fixation System, Openloc-l Spinal Fixation System.
| Device ID | K200790 |
| 510k Number | K200790 |
| Device Name: | LnK Spinal Fixation System, OpenLoc-L Spinal Fixation 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 | Kihyang Kim L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si, KR 17015 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| 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 | 2020-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800108623277 | K200790 | 000 |
| 08800108623260 | K200790 | 000 |
| 08800108623253 | K200790 | 000 |
| 08800108623246 | K200790 | 000 |