The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Lnk Posterior Cervical Fixation System.
| Device ID | K143278 |
| 510k Number | K143278 |
| Device Name: | LnK Posterior Cervical Fixation System |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | L&K BIOMED Co., Ltd. #201,202 16-25 Dongbaekjungang-ro 16 Beon-gil Giheung-gu,yongin-si, KR 446-916 |
| Contact | An Yerim |
| Correspondent | Yerim An L&K BIOMED Co., Ltd. #201,202 16-25 Dongbaekjungang-ro 16 Beon-gil Giheung-gu,yongin-si, KR 446-916 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-14 |
| Decision Date | 2015-07-29 |
| Summary: | summary |