Cleared Traditional

Vertu? & Vertu? Ti-Bond and Crystal? & Crystal? Ti-Bond Cervical Interbody System

K153352 · Spinal Elements, Inc. · Orthopedic

Aug 2016

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K153352 is an FDA 510(k) clearance for the Vertu? & Vertu? Ti-Bond and Crystal? & Crystal? Ti-Bond Cervical Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 1, 2016, 255 days after receiving the submission on November 20, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K153352 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2015
Decision Date	August 01, 2016
Days to Decision	255 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.