The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Openloc-l Spinal Fixation System.
| Device ID | K183168 |
| 510k Number | K183168 |
| Device Name: | 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 | 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 |
| 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 | 2018-11-16 |
| Decision Date | 2018-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806344397149 | K183168 | 000 |
| 08806344397132 | K183168 | 000 |
| 08806344397125 | K183168 | 000 |
| 08806344397118 | K183168 | 000 |