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 | K151677 |
510k Number | K151677 |
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 | 2015-06-22 |
Decision Date | 2015-07-15 |
Summary: | summary |