The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Osteon Ii.
| Device ID | K112716 |
| 510k Number | K112716 |
| Device Name: | OSTEON II |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | GENOSS CO., LTD. 1F GYEONGGI R&D CENTER 906-5 IUI-DONG Suwon-si Yeongtong-gu, Gyeongg, KR 443-270 |
| Contact | Sungwon Lee |
| Correspondent | Sungwon Lee GENOSS CO., LTD. 1F GYEONGGI R&D CENTER 906-5 IUI-DONG Suwon-si Yeongtong-gu, Gyeongg, KR 443-270 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-19 |
| Decision Date | 2012-01-17 |
| Summary: | summary |