SCY — Sacroiliac Joint Guidewire Placement Device Class II
FDA product code SCY covers "Sacroiliac Joint Guidewire Placement Device", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SCY
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241895 | spineguard | Cannulated PsiFGuard | September 26, 2024 |