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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, smooth
510(k) Number K121008
Device Name TRILLIANT SURGICAL K-WIRES
Applicant
TRILLIANT SURGICAL LTD
6721 Portwest Dr Ste 160
Houston,  TX  77024
Applicant Contact J.D. WEBB
Correspondent
TRILLIANT SURGICAL LTD
6721 Portwest Dr Ste 160
Houston,  TX  77024
Correspondent Contact J.D. WEBB
Regulation Number888.3040
Classification Product Code
HTY  
Date Received04/03/2012
Decision Date 06/04/2012
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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