Cleared Traditional

MAVERICK External Fixation System

K213874 · Smith & Nephew, Inc. · Orthopedic
Feb 2022
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K213874 is an FDA 510(k) clearance for the MAVERICK External Fixation System, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 11, 2022, 60 days after receiving the submission on December 13, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K213874 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2021
Decision Date February 11, 2022
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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