FDA 510(k)

MONDRIAN Lumbar Interbody Fusion Cage System

Número K: K192863 · 2020-08-26

Data da decisão2020-08-26

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MONDRIAN Lumbar Interbody Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K192863. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MONDRIAN Lumbar Interbody Fusion Cage System?

MONDRIAN Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Ctl Medical Corporation. The 510(k) number is K192863.

When did MONDRIAN Lumbar Interbody Fusion Cage System receive FDA 510(k) clearance?

MONDRIAN Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2020-08-26, under 510(k) number K192863.

Who is the listed applicant for MONDRIAN Lumbar Interbody Fusion Cage System?

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

What is the FDA product code for MONDRIAN Lumbar Interbody Fusion Cage System?

The FDA product code for MONDRIAN Lumbar Interbody Fusion Cage System is MAX.

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Outros registros que listam Ctl Medical Corporation como candidato(a)

K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System K231715MONDRIAN™ Anterior Lumbar Plate System K231359RODIN™ Expandable Lumbar Cage System K220513NITRO Interbody Fusion Cage System Family K220334MONET Anterior Cervical Plate System K211785CASSATT™ SIJ Fixation System

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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