FDA 510(k)

icotec Cervical Cage

Número K: K192897 · 2020-03-20

Data da decisão2020-03-20

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

icotec Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K192897. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the icotec Cervical Cage?

icotec Cervical Cage is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Icotec AG. The 510(k) number is K192897.

When did icotec Cervical Cage receive FDA 510(k) clearance?

icotec Cervical Cage received FDA 510(k) clearance on 2020-03-20, under 510(k) number K192897.

Who is the listed applicant for icotec Cervical Cage?

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 icotec Cervical Cage?

The FDA product code for icotec Cervical Cage is ODP.

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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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Dispositivos Relacionados (Código: ODP)

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Fonte oficial

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