The following data is part of a premarket notification filed by L&k Biomed Co., Ltd with the FDA for Lnk Cervical Interbody Fusion Cage System.
| Device ID | K143360 |
| 510k Number | K143360 |
| Device Name: | LnK Cervical Interbody Fusion Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | L&K BIOMED Co., Ltd #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si, KR 446-916 |
| Contact | Yerim An |
| 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-04-03 |
| Summary: | summary |