Cleared Special

Velofix Interbody Fusion System

K190067 · U&I Corporation · Orthopedic

Feb 2019

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K190067 is an FDA 510(k) clearance for the Velofix Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on February 4, 2019, 20 days after receiving the submission on January 15, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190067 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 2019
Decision Date	February 04, 2019
Days to Decision	20 days
Submission Type	Special
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.