Cleared Traditional

VUSION CS PLUS

K122588 · Ortho Development Corp. · Orthopedic

Jun 2013

Decision

292d

Days

Class 2

Risk

About This 510(k) Submission

K122588 is an FDA 510(k) clearance for the VUSION CS PLUS, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on June 12, 2013, 292 days after receiving the submission on August 24, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K122588 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2012
Decision Date	June 12, 2013
Days to Decision	292 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, 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.