Cleared Special

LumiVy? Lumbar IBF System

K223412 · Vy Spine, LLC · Orthopedic

Jan 2023

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K223412 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 (Tallahassee, US). The FDA issued a Cleared decision on January 6, 2023, 58 days after receiving the submission on November 9, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223412 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 09, 2022
Decision Date	January 06, 2023
Days to Decision	58 days
Submission Type	Special
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.