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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K153338
Device Name Tiger Cannulated Screw System
Applicant
Trilliant Surgical, Ltd.
6721 Portwest Dr., Suite 160
Houston,  TX  77024
Applicant Contact Jon Olson
Correspondent
The Orthomedix Group
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/19/2015
Decision Date 01/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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