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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 K142520
Device Name Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
Applicant
Smith & Nephew, Inc
1450 Brooks Road
Memphis,  TN  38116
Applicant Contact Martin Ostmann
Correspondent
Smith & Nephew, Inc
1450 Brooks Road
Memphis,  TN  38116
Correspondent Contact Martin Ostmann
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
OSN  
Date Received09/08/2014
Decision Date 11/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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