FDA 510(k)

Duet™ Spinal Fixation System

Numéro K : K253169 · 2026-02-23

Date de décision2026-02-23

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Duet™ Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Box Spine, LLC. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253169. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Duet™ Spinal Fixation System?

Duet™ Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Box Spine, LLC. The 510(k) number is K253169.

When did Duet™ Spinal Fixation System receive FDA 510(k) clearance?

Duet™ Spinal Fixation System received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253169.

Who is the listed applicant for Duet™ Spinal Fixation System?

The FDA 510(k) record lists Box Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Duet™ Spinal Fixation System?

The FDA product code for Duet™ Spinal Fixation System is NKB.

Essais cliniques associés

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Dispositifs connexes (Code : NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Source officielle

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