FDA 510(k)

KHEIRON® Spinal Fixation System, including patient specific K-ROD

N.º K: K262828 · 2026-09-04

SolicitanteS.M.A.I.O

Fecha de decisión2026-09-04

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

KHEIRON® Spinal Fixation System, including patient specific K-ROD is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K262828. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KHEIRON® Spinal Fixation System, including patient specific K-ROD?

KHEIRON® Spinal Fixation System, including patient specific K-ROD is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is S.M.A.I.O. The 510(k) number is K262828.

When did KHEIRON® Spinal Fixation System, including patient specific K-ROD receive FDA 510(k) clearance?

KHEIRON® Spinal Fixation System, including patient specific K-ROD received FDA 510(k) clearance on 2026-09-04, under 510(k) number K262828.

Who is the listed applicant for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA 510(k) record lists S.M.A.I.O as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD is NKB.

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Otros registros que enlistan a S.M.A.I.O como solicitante

K261500KBA3D (v2.4.0)K253802KHEIRON® Spinal Fixation System, including patient specific K-ROD K260786KHEIRON® Spinal Fixation System, including patient specific K-ROD K253990KHEIRON® Spinal Fixation System, including patient specific K-ROD K253721KHEIRON® Spinal Fixation System, including patient specific K-ROD K251804KHEIRON® Spinal Fixation System, including patient specific K-ROD

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Fuente oficial

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