SIQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intra-Articular Orthopedic Stereotaxic Navigation Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4561
- Medical specialty
- Orthopedic
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| TESSA Spatial Surgery System; INTELLIO Tablet (72205455) (DEN250037) | Smith & Nephew, Inc. | 2026-07-06 |
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