De Novo DEN210058
- Device
- ELEOSx™ Limb Salvage System
- Contact
- matthew (matt) vernak
- De Novo number
- DEN210058
- Product code
- QZZ
- Regulation
- 888.3900
- Classification name
- limb and joint salvage device with coating for bacteria reduction
- Decision
- granted (DENG)
- Decision date
- 2024-04-05
- Date received
- 2021-12-30
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QZZ
- Device name
- Limb And Joint Salvage Device With Coating For Bacteria Reduction
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.3900
- Implant
- Y
- Life sustain/support
- N