510(k) K253432
K253432 is an FDA 510(k) premarket notification submitted by Vy Spine, LLC for the device "DiversiVy Facet Screw System". The FDA issued a decision of Substantially Equivalent on March 19, 2026. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Vy Spine, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2026
- Date Received
- October 1, 2025
- 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