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De Novo DEN210044
- Device
- CERAMENT G
- Contact
- blerta shuka
- De Novo number
- DEN210044
- Product code
- QRR
- Regulation
- 888.3046
- Classification name
- filler, bone void, calcium compound containing single approved aminoglycoside
- Decision
- granted (DENG)
- Decision date
- 2022-05-17
- Date received
- 2021-09-28
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QRR
- Device name
- Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.3046
- Implant
- Y
- Life sustain/support
- N