DEN250037
- 510(k) number
- DEN250037
- Device name
- TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- Applicant
- Smith & Nephew, Inc. MA · US
- Product code
- SIQ — Intra-Articular Orthopedic Stereotaxic Navigation In
- Decision date
- 2026-07-06
- Date received
- 2025-08-22
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Orthopedic
Official FDA record: DEN250037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.