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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K200991
Device Name EVOL Spinal Interbody System
Applicant
Cutting Edge Spine, LLC
101 Waxhaw Professional Park, Suite A
Waxhaw,  NC  28173
Applicant Contact Kyle Kuntz
Correspondent
Cutting Edge Spine, LLC
101 Waxhaw Professional Park, Suite A
Waxhaw,  NC  28173
Correspondent Contact Kyle Kuntz
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/15/2020
Decision Date 05/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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