FDA 510(k)

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0

Número K: K190545 · 2019-06-20

Data da decisão2019-06-20

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K190545. 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 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Icotec AG. The 510(k) number is K190545.

When did VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 receive FDA 510(k) clearance?

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 received FDA 510(k) clearance on 2019-06-20, under 510(k) number K190545.

Who is the listed applicant for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

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

What is the FDA product code for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

The FDA product code for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is NKB.

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Outros registros que listam Icotec AG como candidato(a)

K252327CMORE® CT System; CMORE® CT System Navigated Instruments K242900VADER® Pedicle System and VADER®one Pedicle System K233215icotec Anterior Cervical Plate System K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)K232790KONG®-TL VBR System and KONG® C VBR System K232628VADER® Pedicle System

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Fonte oficial

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