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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 Integrated Fixation, Cervical
510(k) Number K200543
Device Name NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
Applicant
Nexxt Spine, LLC
14425 Bergen Blvd.
Suite B
Noblesville,  IN  46060
Applicant Contact Andy Elsbury
Correspondent
Backroads Consulting
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3080
Classification Product Code
OVE  
Date Received03/03/2020
Decision Date 03/23/2020
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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