De Novo DEN230012
- Device
- Ruthless Spine RJB
- Contact
- renita howard
- De Novo number
- DEN230012
- Product code
- QWL
- Regulation
- 888.4560
- Classification name
- intraoperative surgical angle measurement tool
- Decision
- granted (DENG)
- Decision date
- 2023-07-14
- Date received
- 2023-02-16
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QWL
- Device name
- Intraoperative Surgical Angle Measurement Tool
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.4560
- Implant
- Y
- Life sustain/support
- N