The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Osteon, Osteon Sinus, Osteon Lifting.
| Device ID | K102015 |
| 510k Number | K102015 |
| Device Name: | OSTEON, OSTEON SINUS, OSTEON LIFTING |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress, CA 90630 |
| Contact | Eunkyung Son |
| Correspondent | Eunkyung Son GENOSS CO., LTD. 11075 KNOTT AVE., SUITE A Cypress, CA 90630 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-16 |
| Decision Date | 2010-11-19 |
| Summary: | summary |