510(k) K243265
K243265 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "Ion 3D". The FDA issued a decision of Substantially Equivalent on December 4, 2024. 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
- December 4, 2024
- Date Received
- October 15, 2024
- Clearance Type
- Special
- 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