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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 K070724
Device Name IOS EXTERNAL FIXATOR, MODEL 2-0-0
Applicant
INTELLIGENT ORTHOPAEDICS LTD
BRIERFIELD MILL
BRIERFIELD, NELSON,  GB BB9 5NJ
Applicant Contact Neil McLachlan
Correspondent
INTELLIGENT ORTHOPAEDICS LTD
BRIERFIELD MILL
BRIERFIELD, NELSON,  GB BB9 5NJ
Correspondent Contact Neil McLachlan
Regulation Number888.3030
Classification Product Code
KTT  
Date Received03/15/2007
Decision Date 05/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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