510(k) K232468
K232468 is an FDA 510(k) premarket notification submitted by Sc Medica for the device "SC Medica FFX". The FDA issued a decision of Substantially Equivalent on May 9, 2024. 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
- May 9, 2024
- Date Received
- August 15, 2023
- 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