Intra-Articular Orthopedic Stereotaxic Navigation Instrument
SIQ is the FDA product code for Intra-Articular Orthopedic Stereotaxic Navigation Instrument, a class II device type, regulated under 21 CFR 888.4561. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SIQ
- Device name
- Intra-Articular Orthopedic Stereotaxic Navigation Instrument
- 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.
- Regulation
- 21 CFR 888.4561
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SIQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SIQ| Applicant | Clearances |
|---|---|
| Smith & Nephew, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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