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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K220291
Device Name NEXXT SPINE NAVIGATION 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 Number882.4560
Classification Product Code
OLO  
Date Received02/01/2022
Decision Date 03/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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