meddevicedb.com FDA Device Reference

TESSA Spatial Surgery System; INTELLIO Tablet (72205455)

DEN250037 Class II Direct
Decision Date
2026-07-06
Sponsor / Applicant
Smith & Nephew, Inc.

Technical Specification

510(k) Submission ID DEN250037
Product Code SIQ
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.4561
Decision Date 2026-07-06
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

TESSA Spatial Surgery System; INTELLIO Tablet (72205455) received FDA 510(k) clearance under submission number DEN250037, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-07-06.

Classification & Regulation

This clearance is catalogued under FDA product code SIQ and 21 CFR 888.4561, within the Orthopedic review panel as a Class II device.