Cleared Traditional

ONX Large External Fixation System

K213905 · Orthonovis, Inc. · Orthopedic

Aug 2022

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K213905 is an FDA 510(k) clearance for the ONX Large External Fixation System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Orthonovis, Inc. (Palm Coast, US). The FDA issued a Cleared decision on August 25, 2022, 254 days after receiving the submission on December 14, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K213905 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2021
Decision Date	August 25, 2022
Days to Decision	254 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