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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 K052605
Device Name EXTERNAL FIXATION
Applicant
Gexfix USA, Inc.
1200 Clint Moore Rd., Suite 1
Boca Raton,  FL  33487
Applicant Contact LUCIO IMPROTA
Correspondent
Gexfix USA, Inc.
1200 Clint Moore Rd., Suite 1
Boca Raton,  FL  33487
Correspondent Contact LUCIO IMPROTA
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/21/2005
Decision Date 11/10/2005
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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