K250072

CONDUIT™ SYNFIX™ Evolution Secured Spacer System

510(k) number
K250072
Device name
CONDUIT™ SYNFIX™ Evolution Secured Spacer System
Applicant
Avalign Technologies, Inc. IN · US
Product code
OVD — Intervertebral Fusion Device With Integrated Fixatio
Decision date
2025-07-10
Date received
2025-01-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K250072.pdf

Official FDA record: K250072
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.