Cleared Traditional

K202054 - Dynex Ring Fixation System, Diametrix Ring Fixation System
(FDA 510(k) Clearance)

K202054 · Vilex, LLC · Orthopedic
Aug 2020
Decision
31d
Days
Class 2
Risk

K202054 is an FDA 510(k) clearance for the Dynex Ring Fixation System, Diametrix Ring Fixation System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on August 24, 2020, 31 days after receiving the submission on July 24, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K202054 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2020
Decision Date August 24, 2020
Days to Decision 31 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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