510(k) K261209
K261209 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "Ion-L". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. SurGenTec, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2026
- Date Received
- April 13, 2026
- 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