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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 K140463
Device Name INTEGRA EXTERNAL FIXATION SYSTEM
Applicant
ASCENSION ORTHOPEDIC
560 W. GOLF COURSE ROAD
PROVIDENCE,  UT  84332
Applicant Contact STEVE BROWN
Correspondent
ASCENSION ORTHOPEDIC
560 W. GOLF COURSE ROAD
PROVIDENCE,  UT  84332
Correspondent Contact STEVE BROWN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received02/24/2014
Decision Date 10/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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