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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K111025
Device Name TRIGEN LOW PROFILE BONE SCREW
Applicant
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact NATALIE P WILLIAMS
Correspondent
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact NATALIE P WILLIAMS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/13/2011
Decision Date 07/01/2011
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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