Cleared Traditional

LumiVy Lumbar IBF System

K212930 · Vy Spine, LLC · Orthopedic

Feb 2022

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K212930 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 February 16, 2022, 155 days after receiving the submission on September 14, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K212930 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2021
Decision Date	February 16, 2022
Days to Decision	155 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.