Cleared Traditional

Z-LINK CERVICAL

K141005 · Zavation, LLC · Orthopedic

Aug 2014

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K141005 is an FDA 510(k) clearance for the Z-LINK CERVICAL, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on August 7, 2014, 111 days after receiving the submission on April 18, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K141005 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2014
Decision Date	August 07, 2014
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.