The following data is part of a premarket notification filed by Cg Bio Co., Ltd. with the FDA for Lumfix Spinal Fixation Sytem.
Device ID | K160731 |
510k Number | K160731 |
Device Name: | LumFix Spinal Fixation Sytem |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | CG BIO CO., LTD. 244, GALMACHI-RO, JUNGWON-GU Seongnam-si, KR 13211 |
Contact | Yuna Jeong |
Correspondent | April Lee WITHUS GROUP INC 2531 PEPPERDALE DRIVE Rowland Heights, CA 91748 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-17 |
Decision Date | 2016-10-04 |
Summary: | summary |