The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Accelfix Lumbar Interbody Fusion Cage System.
Device ID | K190708 |
510k Number | K190708 |
Device Name: | AccelFix Lumbar Interbody Fusion Cage System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
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 | Kihyang Kim L&K Biomed Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si, KR 17015 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-19 |
Decision Date | 2019-09-16 |
Summary: | summary |