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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 K150321
Device Name EVOS Lumbar Interbody System
Cutting Edge Spine, LLC
101 waxhaw professional park, suite a
waxhaw,  NC  28173
Applicant Contact john souza
Cutting Edge Spine, LLC
101 waxhaw professional park drive, suite a
waxhaw,  NC  28173
Correspodent Contact john souza
Regulation Number888.3080
Classification Product Code
Date Received02/09/2015
Decision Date 07/13/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No