FDA 510(k)

CONDUIT SYNFIX Evolution Secured Spacer System

K-Number: K250072 · 2025-07-10

Decision Date2025-07-10

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CONDUIT SYNFIX Evolution Secured Spacer System is a medical device manufactured by Avalign Technologies, Inc.. It received FDA 510(k) clearance on 2025-07-10 under approval number K250072. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONDUIT SYNFIX Evolution Secured Spacer System?

CONDUIT SYNFIX Evolution Secured Spacer System is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by Avalign Technologies, Inc.. The 510(k) number is K250072.

When was CONDUIT SYNFIX Evolution Secured Spacer System approved by the FDA?

CONDUIT SYNFIX Evolution Secured Spacer System received FDA 510(k) clearance on 2025-07-10, under approval number K250072.

What company makes CONDUIT SYNFIX Evolution Secured Spacer System?

CONDUIT SYNFIX Evolution Secured Spacer System is manufactured by Avalign Technologies, Inc..

What is the FDA product code for CONDUIT SYNFIX Evolution Secured Spacer System?

The FDA product code for CONDUIT SYNFIX Evolution Secured Spacer System is OVD.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.