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FDA 510(k)

DYNEX® External Fixation Systems

K-Number: K260900 · 2026-04-17

ApplicantVilex, LLC
Decision Date2026-04-17
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNEX® External Fixation Systems is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2026-04-17 under approval number K260900. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNEX® External Fixation Systems?

DYNEX® External Fixation Systems is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Vilex, LLC. The 510(k) number is K260900.

When was DYNEX® External Fixation Systems approved by the FDA?

DYNEX® External Fixation Systems received FDA 510(k) clearance on 2026-04-17, under approval number K260900.

What company makes DYNEX® External Fixation Systems?

DYNEX® External Fixation Systems is manufactured by Vilex, LLC.

What is the FDA product code for DYNEX® External Fixation Systems?

The FDA product code for DYNEX® External Fixation Systems is KTT.

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Related PubMed Literature

PMID: 41613162 Evaluating Translational AI: A Two-Way Moving Target Problem. NEJM AI (2025)

Other Devices by Vilex, LLC

K202143Dynex Micro K202054Dynex Ring Fixation System, Diametrix Ring Fixation System K212552Correx Software K221342REDEMPTION Beaming System K221558ALPHALOK Plating System K212348ALPHALOK™ Plating System

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Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

Official Source

View on FDA Database →

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

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