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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
Smith & Nephew, Inc
1450 Brooks Road
memphis,  TN  38116
Applicant Contact martin ostmann
Smith & Nephew, Inc
1450 Brooks Road
memphis,  TN  38116
Correspondent Contact martin ostmann
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
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