Cleared Traditional

Velofix SA Cervical Cage

K210573 · U&I Corporation · Orthopedic

Nov 2021

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K210573 is an FDA 510(k) clearance for the Velofix SA Cervical Cage, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on November 19, 2021, 266 days after receiving the submission on February 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K210573 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2021
Decision Date	November 19, 2021
Days to Decision	266 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.