The following data is part of a premarket notification filed by Jmt Co., Ltd with the FDA for Eden Spinal Fixation System.
| Device ID | K201788 |
| 510k Number | K201788 |
| Device Name: | EDEN Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | JMT Co., Ltd 70-39, Gwonyul-ro 1203 Beon-gile, Baekseok-eup Yangju-si, KR 11517 |
| Contact | Sang-Ok Nam |
| Correspondent | Priscilla Chung Lk Consulting Group USA, Inc. 1150 Roosevelt STE 200 IRVINE, CA 92620 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2022-06-23 |