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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 K031875
Device Name INTER-OS LIMB LENGTHENER
Applicant
Inter-Os Technologies
7430 E. Park Meadows Dr.
Suite 300
Lone Tree,  CO  80124
Applicant Contact RANDOLPH C ROBINSON
Correspondent
Inter-Os Technologies
7430 E. Park Meadows Dr.
Suite 300
Lone Tree,  CO  80124
Correspondent Contact RANDOLPH C ROBINSON
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/17/2003
Decision Date 10/22/2003
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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