Cleared Traditional

Duet? Spinal Fixation System

K253169 · Box Spine, LLC · Orthopedic

Feb 2026

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K253169 is an FDA 510(k) clearance for the Duet? Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Box Spine, LLC (Tulsa, US). The FDA issued a Cleared decision on February 23, 2026, 150 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K253169 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	February 23, 2026
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.