Cleared Traditional

Dynex Micro

K202143 · Vilex, LLC · Orthopedic

Sep 2020

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K202143 is an FDA 510(k) clearance for the Dynex Micro, 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 September 11, 2020, 42 days after receiving the submission on July 31, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K202143 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2020
Decision Date	September 11, 2020
Days to Decision	42 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