Vy Spine VyLam Laminoplasty System— 510(k) K242784

Name: FDA 510(k) clearance K242784
Creator: U.S. Food and Drug Administration
Published: 2024-10-16

Substantially Equivalent

Vy Spine, LLC

FDA 510(k) clearance K242784 for Vy Spine VyLam Laminoplasty System, Substantially Equivalent on 2024-10-16. Applicant: Vy Spine, LLC. Device class: 2.

Clearance details

Applicant: Vy Spine, LLC
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2024-09-16
Decision date: 2024-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Bountiful, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQW

view all

K252930 — AQUA Laminoplasty Systems2026-05-27
K243137 — Curiteva Porous PEEK Laminoplasty System2024-10-28
K232471 — Vy Spine VyLam Laminoplasty System2023-10-10
K231232 — Curiteva Laminoplasty System2023-06-28
K212428 — Centerpiece Plate Fixation System2021-12-13

More clearances from Vy Spine, LLC

view all

K260697 — VyPlate Anterior Cervical Plate System2026-03-27
K253432 — DiversiVy Facet Screw System2026-03-19
K253158 — VyBrate VBR System2026-01-07
K241783 — FortiVy OsteoVy Lumbar IBF2025-03-18
K233807 — LumiVy Lumbar IBF System2024-09-24

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