The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Accelfix Spinal Fixation System.
Device ID | K182544 |
510k Number | K182544 |
Device Name: | AccelFix Spinal Fixation System |
Classification | Thoracolumbosacral Pedicle Screw System |
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 | Jihyeon Seo L&K BioMed Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si, KR 17015 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-17 |
Decision Date | 2019-05-28 |