Cleared Traditional

SCARLET? AC-T Secured Anterior Cervical Cage

K143214 · Spineart · Orthopedic

Feb 2015

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K143214 is an FDA 510(k) clearance for the SCARLET? AC-T Secured Anterior Cervical Cage, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on February 23, 2015, 105 days after receiving the submission on November 10, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K143214 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 2014
Decision Date	February 23, 2015
Days to Decision	105 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.