Cleared Traditional

VyLink? Spinal Screw System

K213750 · Vy Spine, LLC · Orthopedic

Feb 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K213750 is an FDA 510(k) clearance for the VyLink? Spinal Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on February 28, 2022, 90 days after receiving the submission on November 30, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K213750 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2021
Decision Date	February 28, 2022
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.