Cleared Traditional

VariLift-L Interbody Fusion Device

K151900 · Wenzel Spine, Inc. · Orthopedic

Dec 2015

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K151900 is an FDA 510(k) clearance for the VariLift-L Interbody Fusion Device, 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 December 11, 2015, 154 days after receiving the submission on July 10, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K151900 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2015
Decision Date	December 11, 2015
Days to Decision	154 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.