FDA 510(k)

MAVERICK Mini External Fixation System

K-Number: K223112 · 2022-12-08

Decision Date2022-12-08

Product CodeJDW

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MAVERICK Mini External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K223112. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAVERICK Mini External Fixation System?

MAVERICK Mini External Fixation System is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K223112.

When did MAVERICK Mini External Fixation System receive FDA 510(k) clearance?

MAVERICK Mini External Fixation System received FDA 510(k) clearance on 2022-12-08, under 510(k) number K223112.

Who is the listed applicant for MAVERICK Mini External Fixation System?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAVERICK Mini External Fixation System?

The FDA product code for MAVERICK Mini External Fixation System is JDW.

Related Clinical Trials

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: JDW)

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC K241357XT3 SystemBiodynamik, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH K210784Extended HA Half PinsSmith & Nephew, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.