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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K091258
Device Name EXTRAFIX EXTERNAL FIXATION SYSTEM
Applicant
Qfx Technologies, Inc.
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact MARCOS VELEZ-DURAN
Correspondent
Qfx Technologies, Inc.
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact MARCOS VELEZ-DURAN
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received04/29/2009
Decision Date 07/24/2009
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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