The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Osteon Iii.
| Device ID | K153676 |
| 510k Number | K153676 |
| Device Name: | OSTEON III |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | GENOSS CO., LTD. 1F GYEONGGI R&DB CENTER, 105 GWANGGYO-RO, YEONGTONG-GU Suwon-si, KR 433-270 |
| Contact | Eunsang Lee |
| Correspondent | Eunsang Lee GENOSS CO., LTD. 1F GYEONGGI R&DB CENTER, 105 GWANGGYO-RO, YEONGTONG-GU Suwon-si, KR 433-270 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-09-14 |
| Summary: | summary |