Cleared Traditional

VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System

K180822 · Wenzel Spine, Inc. · Orthopedic

Jan 2019

Decision

304d

Days

Class 2

Risk

About This 510(k) Submission

K180822 is an FDA 510(k) clearance for the VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Wenzel Spine, Inc. (Austin, US). The FDA issued a Cleared decision on January 28, 2019, 304 days after receiving the submission on March 30, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K180822 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2018
Decision Date	January 28, 2019
Days to Decision	304 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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