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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
PO BOX 566
Chesterland,  OH  44026 -0566
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
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