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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 K253169
Device Name Duet™ Spinal Fixation System
Applicant
Box Spine, LLC
9524 E. 81st, Suite B1614
Tulsa,  OK  74133
Applicant Contact Troy Walters
Correspondent
Applied Technical Services (Empirical Technologies)
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/26/2025
Decision Date 02/23/2026
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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