MAVERICK External Fixation System

Pin, Fixation, Threaded

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Maverick External Fixation System.

Pre-market Notification Details

Device IDK213874
510k NumberK213874
Device Name:MAVERICK External Fixation System
ClassificationPin, Fixation, Threaded
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactBrad Sheals
CorrespondentBrad Sheals
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-13
Decision Date2022-02-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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