Cleared Traditional

FortiVy? OsteoVy? Lumbar IBF

K241783 · Vy Spine, LLC · Orthopedic

Mar 2025

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K241783 is an FDA 510(k) clearance for the FortiVy? OsteoVy? Lumbar IBF, 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 March 18, 2025, 271 days after receiving the submission on June 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K241783 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	March 18, 2025
Days to Decision	271 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.