Cleared Traditional

VARILIFT-L INTERBODY FUSION DEVICE

K131296 · Wenzel Spine, Inc. · Orthopedic

Sep 2013

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K131296 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 September 3, 2013, 120 days after receiving the submission on May 6, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K131296 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2013
Decision Date	September 03, 2013
Days to Decision	120 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.