K241895 is an FDA 510(k) clearance for the Cannulated PsiFGuard. This device is classified as a Sacroiliac Joint Guidewire Placement Device (Class II - Special Controls, product code SCY).
Submitted by Spineguard (Vincennes, FR). The FDA issued a Cleared decision on September 26, 2024, 90 days after receiving the submission on June 28, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. 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..
| 510(k) Number | K241895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2024 |
| Decision Date | September 26, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | SCY - Sacroiliac Joint Guidewire Placement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| 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. |