The following data is part of a premarket notification filed by B&medi Co., Ltd. with the FDA for Bio-mem Ti Reinforced Membrane.
| Device ID | K210797 |
| 510k Number | K210797 |
| Device Name: | Bio-MEM Ti Reinforced Membrane |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | B&Medi Co., Ltd. 56-33, Chukhang-daero 296Beon-gil, Jung-gu Incheon, KR 22339 |
| Contact | Taesu Kwon |
| Correspondent | Taesu Kwon B&Medi Co., Ltd. 56-33, Chukhang-daero 296Beon-gil, Jung-gu Incheon, KR 22339 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-16 |
| Decision Date | 2022-08-18 |