Osteon II DT7G0210010
by Genoss
Osteon II DT7G0210010 is a Class II device made by Genoss, cleared under FDA 510(k) K112716 on 17 Jan 2012 and listed in FDA GUDID since 14 Mar 2016 (UDI-DI 08809324764153), 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 | Number08809324764153 | Date14 Mar 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112716 | Date17 Jan 2012 | StatusActive |
Official records
- AccessGUDID record 08809324764153
- FDA 510(k) database K112716
Across registries
- FDA 510(k) K112716 decided 17 Jan 2012 Active
- FDA GUDID UDI-DI 08809324764153 listed 14 Mar 2016 Listed
Timeline
- Cleared FDA 510(k) K112716
- Listed FDA GUDID 08809324764153
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Osteon II
- Generic name
- Synthetic bone graft
- Model / Ref / Catalog
- DT7G0210010
- Primary DI / UDI-DI
- 08809324764153
- 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 — 0.1 Milliliter
Similar devices in this category
Other devices filed under Synthetic bone graft.