PMA P210016
- Device
- ManaFuse
- Applicant
- Enovis
- PMA number
- P210016
- Product code
- LOF
- Decision date
- 2025-01-17
- Classification
- Orthopedic
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- The ManaFuse system is indicated for the non-invasive treatment of established non-unions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature adult individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.
Current openFDA PMA Record#
- Device
- ManaFuse
- Applicant
- Enovis
- PMA number
- P210016
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2025-01-17
- Decision code
- APRL
- Date received
- 2021-04-26
- Approval order statement
- The ManaFuse system is indicated for the non-invasive treatment of established non-unions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature adult individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.