510(k) K251885
K251885 is an FDA 510(k) premarket notification submitted by Providence Medical Technology, Inc. for the device "CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant". The FDA issued a decision of Substantially Equivalent on July 10, 2025. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Providence Medical Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2025
- Date Received
- June 20, 2025
- 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