SCY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sacroiliac Joint Guidewire Placement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Medical specialty
- Orthopedic
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cannulated PsiFGuard (K241895) | Spineguard | 2024-09-26 |
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Every clearance here is in the API, with alerts when new ones post.