FDA 510(k)

Mont Blanc and Mont Blanc MIS Spinal Systems

Número K: K161387 · 2016-08-04

Data da decisão2016-08-04

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mont Blanc and Mont Blanc MIS Spinal Systems is the device name listed in this FDA 510(k) record. The listed applicant is Spineway SA. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K161387. 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 Mont Blanc and Mont Blanc MIS Spinal Systems?

Mont Blanc and Mont Blanc MIS Spinal Systems is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Spineway SA. The 510(k) number is K161387.

When did Mont Blanc and Mont Blanc MIS Spinal Systems receive FDA 510(k) clearance?

Mont Blanc and Mont Blanc MIS Spinal Systems received FDA 510(k) clearance on 2016-08-04, under 510(k) number K161387.

Who is the listed applicant for Mont Blanc and Mont Blanc MIS Spinal Systems?

The FDA 510(k) record lists Spineway SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems?

The FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems is NKB.

Ensaios clínicos relacionados

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Outros registros que listam Spineway SA como candidato(a)

K191726mont blanc & mont blanc MIS Spinal Systems

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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