De Novo DEN250037
- Device
- TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- Contact
- pooja dalvi
- De Novo number
- DEN250037
- Product code
- SIQ
- Regulation
- 888.4561
- Classification name
- intra-articular orthopedic stereotaxic navigation instrument
- Decision
- granted (DENG)
- Decision date
- 2026-07-06
- Date received
- 2025-08-22
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct