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.
1
Total
1
Cleared
90d
Avg days
2024
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Sacroiliac Joint Guidewire Placement Device Devices (Product Code SCY)
1 devices
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.