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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 K070555
Device Name ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES
Applicant
Orthopro, LLC
13115 NE 4th St., Suite 130
Vancouver,  WA  98684
Applicant Contact CHRISTOPHER COOK
Correspondent
Orthopro, LLC
13115 NE 4th St., Suite 130
Vancouver,  WA  98684
Correspondent Contact CHRISTOPHER COOK
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received02/27/2007
Decision Date 07/13/2007
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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