Cleared Traditional

PEEK PREVAIL CERVICAL INTERBODY DEVICE

K094042 · Medtronic Sofamor Danek · Orthopedic

Jun 2010

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K094042 is an FDA 510(k) clearance for the PEEK PREVAIL CERVICAL INTERBODY DEVICE, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on June 30, 2010, 182 days after receiving the submission on December 30, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K094042 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2009
Decision Date	June 30, 2010
Days to Decision	182 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.