Cleared Traditional

ClariVy? Cervical IBF System

K231836 · Vy Spine, LLC · Orthopedic

Oct 2023

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K231836 is an FDA 510(k) clearance for the ClariVy? 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 October 30, 2023, 130 days after receiving the submission on June 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231836 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2023
Decision Date	October 30, 2023
Days to Decision	130 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.