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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K243838
Device Name NEXXT MATRIXX® SI System
Applicant
Nexxt Spine
14425 Bergen Blvd.
Suite B
Noblesville,  IN  46060
Applicant Contact Andy Elsbury
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
HWC  
Date Received12/13/2024
Decision Date 03/14/2025
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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