The following data is part of a premarket notification filed by Genoss Co., Ltd. with the FDA for Osteon, Models Gbg0305, Gbg0510, Gbg1020, Gbg2030, Gbg3040, Gbg4050.
| Device ID | K062834 |
| 510k Number | K062834 |
| Device Name: | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | GENOSS CO., LTD. 28711 JAEGER DRIVE Laguna Niguel, CA 92677 |
| Contact | Klass Besseling |
| Correspondent | Klass Besseling GENOSS CO., LTD. 28711 JAEGER DRIVE Laguna Niguel, CA 92677 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-21 |
| Decision Date | 2007-04-24 |
| Summary: | summary |