The following data is part of a premarket notification filed by Tdm Co., Ltd with the FDA for Tdm Lumbar Interbody Fusion Cage System.
| Device ID | K221844 |
| 510k Number | K221844 |
| Device Name: | TDM Lumbar Interbody Fusion Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | TDM Co., Ltd 69, Cheomdan Venture So-ro 37 Beon-gil, Buk-gu Gwangju, KR 61003 |
| Contact | Jung Wook Choi |
| Correspondent | Jeena Mathai Eerkie Corporation 4027 Runnymeade Dr Collegeville, PA 19426 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-24 |
| Decision Date | 2022-08-17 |