CONDUIT SYNFIX Evolution Secured Spacer System— 510(k) K250072

Name: FDA 510(k) clearance K250072
Creator: U.S. Food and Drug Administration
Published: 2025-07-10

Substantially Equivalent

Avalign Technologies, Inc.

FDA 510(k) clearance K250072 for CONDUIT SYNFIX Evolution Secured Spacer System, Substantially Equivalent on 2025-07-10. Applicant: Avalign Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Avalign Technologies, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-01-10
Decision date: 2025-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

Download summary PDF View on FDA.gov ↗

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K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18
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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.