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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 K160177
Device Name Gridlock Ankle Plating System
Applicant
Trilliant Surgical, LTD
6721 Portwest Dr Ste 160
Houston,  TX  77024
Applicant Contact Jon Olson
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd
Round Rock,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/27/2016
Decision Date 04/22/2016
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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