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FDA 510(k)

Dynex Ring Fixation System, Diametrix Ring Fixation System

K-Number: K202054 · 2020-08-24

ApplicantVilex, LLC
Decision Date2020-08-24
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dynex Ring Fixation System, Diametrix Ring Fixation System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2020-08-24 under approval number K202054. 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 Ring Fixation System, Diametrix Ring Fixation System?

Dynex Ring Fixation System, Diametrix Ring Fixation System is a medical device that received FDA 510(k) clearance on 2020-08-24. It is manufactured by Vilex, LLC. The 510(k) number is K202054.

When was Dynex Ring Fixation System, Diametrix Ring Fixation System approved by the FDA?

Dynex Ring Fixation System, Diametrix Ring Fixation System received FDA 510(k) clearance on 2020-08-24, under approval number K202054.

What company makes Dynex Ring Fixation System, Diametrix Ring Fixation System?

Dynex Ring Fixation System, Diametrix Ring Fixation System is manufactured by Vilex, LLC.

What is the FDA product code for Dynex Ring Fixation System, Diametrix Ring Fixation System?

The FDA product code for Dynex Ring Fixation System, Diametrix Ring Fixation System is KTT.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Vilex, LLC

K202143Dynex Micro 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.

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