510(k) K252153
K252153 is an FDA 510(k) premarket notification submitted by Sc Medica for the device "FFX Facet Fixation System". The FDA issued a decision of Substantially Equivalent on October 16, 2025. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Sc Medica has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2025
- Date Received
- July 9, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type