De Novo DEN140030
- Device
- SpaceOAR System
- Contact
- noel rolon
- De Novo number
- DEN140030
- Product code
- OVB
- Regulation
- 892.5725
- Classification name
- hydrogel spacer
- Decision
- granted (DENG)
- Decision date
- 2015-04-01
- Date received
- 2014-10-01
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- OVB
- Device name
- Hydrogel Spacer
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.5725
- Implant
- N
- Life sustain/support
- N