Skip to contentDe Novo DEN220015
- Device
- Orthobond Mariner Pedicle Screw System
- Contact
- david nichols
- De Novo number
- DEN220015
- Product code
- QZY
- Regulation
- 888.3071
- Classification name
- spinal fusion system with 12-methacryloyloxydodecyl pyridinium bromide (c21h34brno2) coating
- Decision
- granted (DENG)
- Decision date
- 2024-04-05
- Date received
- 2022-02-28
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QZY
- Device name
- Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.3071
- Implant
- Y
- Life sustain/support
- N