Cleared Traditional

UniVy OsteoVy Cervical IBF System

K221162 · Vy Spine, LLC · Orthopedic

Nov 2022

Decision

196d

Days

Class 2

Risk

About This 510(k) Submission

K221162 is an FDA 510(k) clearance for the UniVy OsteoVy 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 November 4, 2022, 196 days after receiving the submission on April 22, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K221162 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2022
Decision Date	November 04, 2022
Days to Decision	196 days
Submission Type	Traditional
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.