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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K142135
Device Name REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
Applicant
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
6 MARS COURT, UNIT 6-3
BOONTON,  NJ  07005
Applicant Contact JAN TRIANI
Correspondent
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
6 MARS COURT, UNIT 6-3
BOONTON,  NJ  07005
Correspondent Contact JAN TRIANI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/04/2014
Decision Date 08/28/2014
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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