Cleared Traditional

Zavation Z-Link Lumbar

K142271 · Zavation, LLC · Orthopedic

Dec 2014

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K142271 is an FDA 510(k) clearance for the Zavation Z-Link Lumbar, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on December 19, 2014, 126 days after receiving the submission on August 15, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K142271 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2014
Decision Date	December 19, 2014
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.