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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 K032058
Device Name MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
Applicant
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact MOIRA BARTON
Correspondent
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact MOIRA BARTON
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/02/2003
Decision Date 07/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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