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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 K123525
Device Name GRIDLOCK PLATING SYSTEM
Applicant
TRILLIANT SURGICAL LTD
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
TRILLIANT SURGICAL LTD
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/15/2012
Decision Date 02/15/2013
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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