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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 K212378
Device Name Arsenal Ankle Plating System
Applicant
Trilliant Surgical
727 North Shepherd Drive, Suite 100
Houston,  TX  77007
Applicant Contact Sofia Middleton
Correspondent
Trilliant Surgical
727 North Shepherd Drive, Suite 100
Houston,  TX  77007
Correspondent Contact Christopher Radzicki
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC   NDG  
Date Received08/02/2021
Decision Date 02/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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