510(k) K243565
K243565 is an FDA 510(k) premarket notification submitted by Promethean Restorative, LLC for the device "DYNAMIS SI Screw System". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Promethean Restorative, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2025
- Date Received
- November 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sacroiliac Joint Fixation
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
sacroiliac joint fusion