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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 K083912
Device Name TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS
Applicant
Treu-Instrumente GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Applicant Contact FRANZ MENEAN
Correspondent
Treu-Instrumente GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact FRANZ MENEAN
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTY   JDW  
Date Received12/30/2008
Decision Date 07/15/2009
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
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