TESSA Spatial Surgery System; INTELLIO Tablet (72205455)— 510(k) DEN250037
UnknownSmith & Nephew, Inc.
FDA 510(k) clearance DEN250037 for TESSA Spatial Surgery System; INTELLIO Tablet (72205455), Unknown on 2026-07-06. Applicant: Smith & Nephew, Inc.. Device class: 2.
Summary
This Smith & Nephew record names the TESSA Spatial Surgery System and the INTELLIO Tablet (72205455). They're filed under SIQ, intra-articular orthopedic stereotaxic navigation instruments, and the record doesn't list other components.
Class II, 21 CFR 888.4561. Orthopedic is both the classification panel and the review panel. The record lists the submission type as Direct.
Smith & Nephew filed from Andover, Massachusetts. The decision date came 318 calendar days after the received date (August 22, 2025 to July 6, 2026).
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Product code SIQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.4561
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Andover, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.