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 |