FDA 510(k)

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

Número K: K253990 · 2026-01-07

RequerenteS.M.A.I.O

Data da decisão2026-01-07

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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 2026-01-07 under 510(k) number K253990. 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 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 2026-01-07. The listed applicant is S.M.A.I.O. The 510(k) number is K253990.

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 2026-01-07, under 510(k) number K253990.

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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Outros registros que listam S.M.A.I.O como candidato(a)

K262828KHEIRON® Spinal Fixation System, including patient specific K-ROD K261500KBA3D (v2.4.0)K253802KHEIRON® Spinal Fixation System, including patient specific K-ROD K260786KHEIRON® 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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Dispositivos Relacionados (Código: 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.

Fonte oficial

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