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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 K172178
Device Name Minimally Invasive Bunion Plating System
Applicant
Trilliant Surgical, Ltd.
6721 Portwest Dr., Suite 160
Houston,  TX  77024
Applicant Contact Jonathan Olson
Correspondent
Trilliant Surgical, Ltd.
6721 Portwest Dr., Suite 160
Houston,  TX  77024
Correspondent Contact Jonathan Olson
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/19/2017
Decision Date 11/16/2017
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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