FDA product code SCY: Sacroiliac Joint Guidewire Placement Device
SCY is the FDA product code for sacroiliac joint guidewire placement device. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under SCY, 1 in the last five years. The average 510(k) review took 90 days (median 90); 90 days on average over the last three years.
Definition
A sacroiliac joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint.
Classification
| Field | Value |
|---|---|
| Device name | Sacroiliac Joint Guidewire Placement Device |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for SCY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 90 |
Compare with all 510(k) review times · Search every SCY clearance
Top SCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spineguard | 1 | 2024-09-26 |
Most recent SCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241895 | Spineguard | Cannulated PsiFGuard | 2024-09-26 | 90 |
Recalls for SCY devices
openFDA lists no recalls for product code SCY.
Frequently asked questions
What is FDA product code SCY?
SCY is the FDA product code for sacroiliac joint guidewire placement device. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is SCY?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCY?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most SCY clearances?
Spineguard (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCY
- Run a recall and safety report across every SCY manufacturer
- Watch product code SCY 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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