LumiVy Lumbar IBF System— 510(k) K233807

Name: FDA 510(k) clearance K233807
Creator: U.S. Food and Drug Administration
Published: 2024-09-24

Substantially Equivalent

Vy Spine, LLC

FDA 510(k) clearance K233807 for LumiVy Lumbar IBF System, Substantially Equivalent on 2024-09-24. Applicant: Vy Spine, LLC. Device class: 2.

Clearance details

Applicant: Vy Spine, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-11-29
Decision date: 2024-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

view all

K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

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
K242784 — Vy Spine VyLam Laminoplasty System2024-10-16

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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