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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, threaded
510(k) Number K223112
Device Name MAVERICK Mini External Fixation System
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Allison Francis
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Allison Francis
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
KTT  
Date Received10/03/2022
Decision Date 12/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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