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FDA 510(k)

CONDUIT™ SYNFIX™ Evolution Secured Spacer System

K-Number: K250072 · 2025-07-10

ApplicantAvalign Technologies, Inc.
Decision Date2025-07-10
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONDUIT™ SYNFIX™ Evolution Secured Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Avalign Technologies, Inc.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) 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. The listed applicant is Avalign Technologies, Inc.. The 510(k) number is K250072.

When did CONDUIT™ SYNFIX™ Evolution Secured Spacer System receive FDA 510(k) clearance?

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

Who is the listed applicant for CONDUIT™ SYNFIX™ Evolution Secured Spacer System?

The FDA 510(k) record lists Avalign Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Avalign Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemK193066Steripack cases and Tray Systems

Related Devices (Code: OVD)

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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.

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