510(k) K241895
K241895 is an FDA 510(k) premarket notification submitted by Spineguard for the device "Cannulated PsiFGuard". The FDA issued a decision of Substantially Equivalent on September 26, 2024. The device falls under product code SCY (Sacroiliac Joint Guidewire Placement Device), a Class II device regulated under 21 CFR 888.3040. Spineguard has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2024
- Date Received
- June 28, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sacroiliac Joint Guidewire Placement Device
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
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.