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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 K191009
Device Name Arsenal Plating System
Applicant
Trilliant Surgical
727 N. Shepherd Dr., Suite 100
Houston,  TX  77007
Applicant Contact Christopher Radzicki
Correspondent
Trilliant Surgical
727 N. Shepherd Dr., Suite 100
Houston,  TX  77007
Correspondent Contact Christopher Radzicki
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/16/2019
Decision Date 08/12/2019
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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