Cleared Traditional

LumiVy? Lumbar IBF System

K233807 · Vy Spine, LLC · Orthopedic

Sep 2024

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K233807 is an FDA 510(k) clearance for the LumiVy? Lumbar IBF System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Vy Spine, LLC (Bountiful, US). The FDA issued a Cleared decision on September 24, 2024, 300 days after receiving the submission on November 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K233807 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2023
Decision Date	September 24, 2024
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.