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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K231799
Device Name INERTIA® CONNEXX™ Modular Pedicle Screw System
Applicant
Nexxt Spine, LLC
14425 Bergen Blvd.
Suite B
Noblesville,  IN  46060
Applicant Contact Andy Elsbury
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/20/2023
Decision Date 07/20/2023
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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