FDA 510(k)

Duet™ Spinal Fixation System

Número K: K253169 · 2026-02-23

Data da decisão2026-02-23

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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