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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 K202972
Device Name Anterior Cervical Plate System
Applicant
Nutech Spine and Biologics
600 Luckie Dr., Suite 424
Birmingham,  AL  35223
Applicant Contact Grant Horton
Correspondent
Surgop Support
101 Lamond Ct.
Prosper,  TX  75078
Correspondent Contact Daniel Lanois
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/30/2020
Decision Date 11/24/2020
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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