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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K201253
Device Name Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
Applicant
Smith & Nephew
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Applicant Contact Konrad Wolfmeyer
Correspondent
Smith & Nephew
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Correspondent Contact Brad Sheals
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
JDW   LXT   OSN  
Date Received05/11/2020
Decision Date 12/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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