510(k) K243865
K243865 is an FDA 510(k) premarket notification submitted by Aurora Spine for the device "AERO MIS Facet Fusion System". The FDA issued a decision of Substantially Equivalent on March 24, 2025. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Aurora Spine has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2025
- Date Received
- December 17, 2024
- 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