Cleared Traditional

Vy Spine ClariVy Cervical IBF System

K212715 · Vy Spine, LLC · Orthopedic

Dec 2021

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K212715 is an FDA 510(k) clearance for the Vy Spine 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 December 20, 2021, 116 days after receiving the submission on August 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K212715 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2021
Decision Date	December 20, 2021
Days to Decision	116 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.