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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 K101338
Device Name NEWFIX EXTERNAL FIXATION SYSTEM
Applicant
Technologia Y Diseno Industrial, S.A DE C.V
P.O. Box 506
South Lyon,  MI  48178
Applicant Contact ROBERT BARD
Correspondent
Technologia Y Diseno Industrial, S.A DE C.V
P.O. Box 506
South Lyon,  MI  48178
Correspondent Contact ROBERT BARD
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/12/2010
Decision Date 03/14/2011
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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