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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, Single Component
510(k) Number K012634
FOIA Releasable 510(k) K012634
Device Name REPROCESSED EXTERNAL FIXATION DEVICE
Applicant
Alliance Medical, Inc.
10232 S. 51 St.
Phoenix,  AZ  85044
Applicant Contact DON SELVEY
Correspondent
Alliance Medical, Inc.
10232 S. 51 St.
Phoenix,  AZ  85044
Correspondent Contact DON SELVEY
Regulation Number888.3030
Classification Product Code
KTW  
Subsequent Product Codes
JEC   KTT  
Date Received08/13/2001
Decision Date 06/24/2002
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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