ManaFuse
FDA premarket approval P210016 · decided 2025-01-17
Approval details
- PMA number
- P210016
- Trade name
- ManaFuse
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Enovis
- Date received
- 2021-04-26
- Decision date
- 2025-01-17
- Days to decision
- 1362 days
- Decision code
- APRL
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Calrsbadd, NV
- 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.
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