The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Accelfix Spinal Fixation System.
| Device ID | K182544 |
| 510k Number | K182544 |
| Device Name: | AccelFix 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-17 |
| Decision Date | 2019-05-28 |