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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, Spinal Interlaminal
510(k) Number K132900
Device Name MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
Applicant
Intelligent Implant Systems, LLC
3300 International Airport
Drive Suite 1100
Charlotte,  NC  28208
Applicant Contact MICHAEL NUTT
Correspondent
Intelligent Implant Systems, LLC
3300 International Airport
Drive Suite 1100
Charlotte,  NC  28208
Correspondent Contact MICHAEL NUTT
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received09/16/2013
Decision Date 10/25/2013
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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