Cleared Traditional

CONDUIT? SYNFIX? Evolution Secured Spacer System

K250072 · Avalign Technologies, Inc. · Orthopedic

Jul 2025

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K250072 is an FDA 510(k) clearance for the CONDUIT? SYNFIX? Evolution Secured Spacer System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Avalign Technologies, Inc. (Fort Wayne, US). The FDA issued a Cleared decision on July 10, 2025, 181 days after receiving the submission on January 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250072 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2025
Decision Date	July 10, 2025
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.