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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 K173375
Device Name Anterior Cervical Plate System
Applicant
Evolution Spine, LLC
2300 N. Haskell
Dallas,  TX  75204
Applicant Contact Douglas Davis
Correspondent
Evolution Spine, LLC
2300 N. Haskell
Dallas,  TX  75204
Correspondent Contact Douglas Davis
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/27/2017
Decision Date 12/21/2017
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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