OsteonIII 3G0510050
by Genoss
OsteonIII 3G0510050 is a Class II device made by Genoss, cleared under FDA 510(k) K153676 on 14 Sep 2016 and listed in FDA GUDID since 10 Jul 2018 (UDI-DI 08809324768137), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809324768137 | Date10 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153676 | Date14 Sep 2016 | StatusActive |
Official records
- AccessGUDID record 08809324768137
- FDA 510(k) database K153676
Across registries
- FDA 510(k) K153676 decided 14 Sep 2016 Active
- FDA GUDID UDI-DI 08809324768137 listed 10 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K153676
- Listed FDA GUDID 08809324768137
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OsteonIII
- Generic name
- Synthetic bone graft
- Model / Ref / Catalog
- 3G0510050
- Primary DI / UDI-DI
- 08809324768137
- 510(k) Number
- FDA product code
- LYC
- GMDN term
- Synthetic bone graft
- Device class
- Class II
- Regulation number
- 872.3930
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
- Size
- Total Volume — 0.5 Milliliter
Similar devices in this category
Other devices filed under Synthetic bone graft.