The following data is part of a premarket notification filed by Fims Co., Ltd. with the FDA for 3d Cage.
| Device ID | K180347 |
| 510k Number | K180347 |
| Device Name: | 3d Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Fims Co., Ltd. Rm 212 Gyeonggi R&DB Center Suwon 16229 KR Suwon-si, KP 16229 |
| Contact | Younggwang Choi |
| Correspondent | Younggwang Choi Fims Co., Ltd. B1, 440, Ghangnyong-daero, Yeongtong-gu Suwon-si, KR 16229 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2019-10-28 |
| Summary: | summary |