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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device - Cervical
510(k) Number K193412
Device Name NEXXT MATRIXX 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 Number888.3060
Classification Product Code
PLR  
Subsequent Product Code
MQP  
Date Received12/09/2019
Decision Date 02/24/2020
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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