De Novo DEN200035
- Device
- BEAR (Bridge-Enhanced ACL Repair) Implant
- Contact
- martha shadan
- De Novo number
- DEN200035
- Product code
- QNI
- Regulation
- 888.3044
- Classification name
- resorbable implant for anterior cruciate ligament (acl) repair
- Decision
- granted (DENG)
- Decision date
- 2020-12-16
- Date received
- 2020-06-04
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QNI
- Device name
- Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.3044
- Implant
- Y
- Life sustain/support
- N