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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 K262712
Device Name Duet™ Spinal Fixation System
Applicant
Duet Spine Holdings, LLC
P.O. Box 420
Winona Lake,  IN  46590
Applicant Contact Jill Serbousek
Correspondent
ATS Colorado Springs
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/31/2026
Decision Date 09/30/2026
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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