FDA product code SGL: Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
SGL is the FDA product code for manual instruments designed for use with non-fusion spinous process tension band implant. It is a Class II device, regulated under 21 CFR 888.4520 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under SGL, 1 in the last five years. The average 510(k) review took 259 days (median 259); 259 days on average over the last three years.
Definition
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process tension band implant for non-fusion use.
Classification
| Field | Value |
|---|---|
| Device name | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant |
| Device class | Class II |
| Regulation | 21 CFR 888.4520 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for SGL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 259 |
Compare with all 510(k) review times · Search every SGL clearance
Top SGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Empirical Spine | 1 | 2026-06-16 |
Most recent SGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253374 | Empirical Spine | LimiFlex® Dynamic Sagittal Tether Instrument Set | 2026-06-16 | 259 |
Recalls for SGL devices
openFDA lists no recalls for product code SGL.
Frequently asked questions
What is FDA product code SGL?
SGL is the FDA product code for manual instruments designed for use with non-fusion spinous process tension band implant. It is a Class II device, regulated under 21 CFR 888.4520 and reviewed by the Orthopedic panel.
What device class is SGL?
Class II, regulation 21 CFR 888.4520. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGL?
Across 1 cleared submissions the average was 259 days from receipt to decision (median 259).
Which companies have the most SGL clearances?
Empirical Spine (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SGL
- Run a recall and safety report across every SGL manufacturer
- Watch product code SGL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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