De Novo DEN210013
- Device
- OsteoProbe
- Contact
- alexander proctor
- De Novo number
- DEN210013
- Product code
- QGQ
- Regulation
- 888.1600
- Classification name
- bone indentation device
- Decision
- granted (DENG)
- Decision date
- 2021-08-19
- Date received
- 2021-03-30
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QGQ
- Device name
- Bone Indentation Device
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.1600
- Implant
- N
- Life sustain/support
- N