FDA 510(k)

Dynex Micro

K-Number: K202143 · 2020-09-11

Decision Date2020-09-11

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Dynex Micro is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2020-09-11 under approval number K202143. 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 Micro?

Dynex Micro is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Vilex, LLC. The 510(k) number is K202143.

When was Dynex Micro approved by the FDA?

Dynex Micro received FDA 510(k) clearance on 2020-09-11, under approval number K202143.

What company makes Dynex Micro?

Dynex Micro is manufactured by Vilex, LLC.

What is the FDA product code for Dynex Micro?

The FDA product code for Dynex Micro is KTT.

Other Devices by Vilex, LLC

K202054Dynex Ring Fixation System, Diametrix Ring Fixation System K212552Correx Software K221342REDEMPTION Beaming System K221558ALPHALOK Plating System K212348ALPHALOK Plating System K231504TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw 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.