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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 K202762
Device Name Circular Fixation with Balanced Cable Transport
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farm Parkway
Cordova,  TN  38016
Applicant Contact Crystal Higgenbottom-Shaffer
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Crystal Higgenbottom-Shaffer
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/21/2020
Decision Date 11/16/2020
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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