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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 K012062
Device Name PF2
Applicant
Fixano SA
P.O. Box 12038
La Jolla,  CA  92039
Applicant Contact FRANK FERGUSON
Correspondent
Fixano SA
P.O. Box 12038
La Jolla,  CA  92039
Correspondent Contact FRANK FERGUSON
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/02/2001
Decision Date 09/27/2001
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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