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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
Recalls CDRH Recalls
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