Cleared Traditional

MAVERICK Mini External Fixation System

K223112 · Smith & Nephew, Inc. · Orthopedic
Dec 2022
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K223112 is an FDA 510(k) clearance for the MAVERICK Mini 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 December 8, 2022, 66 days after receiving the submission on October 3, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K223112 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2022
Decision Date December 08, 2022
Days to Decision 66 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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