SIQ — Intra-Articular Orthopedic Stereotaxic Navigation Instrument Class II
FDA product code SIQ covers "Intra-Articular Orthopedic Stereotaxic Navigation Instrument", a Class II medical device regulated under 21 CFR 888.4561. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIQ
- Device Class
- Class II
- Regulation Number
- 888.4561
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the intraarticular space. The markers are continuously tracked for precisely positioning instruments or other devices.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250037 | smith and nephew | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | July 6, 2026 |