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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 K201979
Device Name Cervical Plate System
Applicant
Eminent Spine, LLC
1705 Ohio Dr., Suite 300
Plano,  TX  75093
Applicant Contact Stephen Courtney
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/16/2020
Decision Date 08/25/2020
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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