KHEIRON Spinal Fixation System — 510(k) de la FDA K211414

Resumen del dispositivo

KHEIRON Spinal Fixation System 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 2021-08-10 under 510(k) number K211414. 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?

KHEIRON Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is S.M.A.I.O. The 510(k) number is K211414.

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

KHEIRON Spinal Fixation System received FDA 510(k) clearance on 2021-08-10, under 510(k) number K211414.

Who is the listed applicant for KHEIRON Spinal Fixation System?

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?

The FDA product code for KHEIRON Spinal Fixation System is NKB.

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

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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 K253990KHEIRON® Spinal Fixation System, including patient specific K-ROD K253721KHEIRON® Spinal Fixation System, including patient specific K-ROD

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Dispositivos relacionados (Código: NKB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

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