The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Lnk Anterior Cervical Plate System.
| Device ID | K143279 |
| 510k Number | K143279 |
| Device Name: | LnK Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | L&K BIOMED Co., Ltd. #201,202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu,yongin-si, KR 446-916 |
| Contact | Ki-hyang Kim |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-14 |
| Decision Date | 2015-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806344363182 | K143279 | 000 |
| 08806344363175 | K143279 | 000 |
| 08806344363083 | K143279 | 000 |
| 08806344363076 | K143279 | 000 |