K253432
- 510(k) number
- K253432
- Device name
- DiversiVy Facet Screw System
- Applicant
- Vy Spine, LLC UT · US
- Product code
- MRW — System, Facet Screw Spinal Device
- Decision date
- 2026-03-19
- Date received
- 2025-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253432.pdf
Official FDA record: K253432
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.