Cleared Special

UniVy? OsteoVy?-Ti Cervical IBF System

K223513 · Vy Spine, LLC · Orthopedic

Apr 2023

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K223513 is an FDA 510(k) clearance for the UniVy? OsteoVy?-Ti Cervical IBF System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on April 18, 2023, 147 days after receiving the submission on November 22, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223513 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2022
Decision Date	April 18, 2023
Days to Decision	147 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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