Cleared Traditional

VariLift?-C Interbody Fusion System

K231076 · Wenzel Spine, Inc. · Orthopedic

Sep 2023

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K231076 is an FDA 510(k) clearance for the VariLift?-C Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Wenzel Spine, Inc. (Austin, US). The FDA issued a Cleared decision on September 27, 2023, 166 days after receiving the submission on April 14, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231076 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2023
Decision Date	September 27, 2023
Days to Decision	166 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.