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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 K140675
Device Name EMERGE EXTERNAL FIXATION SYSTEM
Applicant
Emerge Medical, Inc.
720 S. Colorodo Blvd. Suite 550-S
Denver,  CO  80246
Applicant Contact MICHELLE POTVIN
Correspondent
Emerge Medical, Inc.
720 S. Colorodo Blvd. Suite 550-S
Denver,  CO  80246
Correspondent Contact MICHELLE POTVIN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received03/18/2014
Decision Date 06/10/2014
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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