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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 Intervertebral Body
510(k) Number K173935
Device Name Mediant Anterior Cervical Plating System
Applicant
Intelligent Implant Systems, LLC
3300 International Airport Dr; Suite 1100
Charlotte,  NC  28208
Applicant Contact Michael Nutt
Correspondent
Intelligent Implant Systems, LLC
3300 International Airport Dr; Suite 1100
Charlotte,  NC  28208
Correspondent Contact Michael Nutt
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/26/2017
Decision Date 04/16/2018
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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