DiversiVy Facet Screw System— 510(k) K253432

Name: FDA 510(k) clearance K253432
Creator: U.S. Food and Drug Administration
Published: 2026-03-19

Substantially Equivalent

Vy Spine, LLC

FDA 510(k) clearance K253432 for DiversiVy Facet Screw System, Substantially Equivalent on 2026-03-19. Applicant: Vy Spine, LLC. Device class: Unclassified.

Summary

Vy Spine's DiversiVy Facet Screw System is filed under MRW, facet screw spinal device systems. The record doesn't list screw sizes or components.

The device class is listed as U, with no regulation number. The classification panel is listed as Unknown, and the Orthopedic review panel handled it as a Traditional 510(k).

Vy Spine filed from Bountiful, Utah. The decision came 169 calendar days after FDA received it (October 1, 2025 to March 19, 2026).

Clearance details

Applicant: Vy Spine, LLC
Product code: Product code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-10-01
Decision date: 2026-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.