FDA Product Code SCY: Sacroiliac Joint Guidewire Placement Device
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.
Leading manufacturers include Spineguard.
FDA 510(k) Cleared Sacroiliac Joint Guidewire Placement Device Devices (Product Code SCY)
About Product Code SCY - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SCY since 2024, with 1 receiving FDA clearance (average review time: 90 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SCY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →