FDA 510(k)

SPIRA Open Matrix LLIF

Número K: K180724 · 2018-06-25

RequerenteCamber Spine Technologies, LLC

Data da decisão2018-06-25

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPIRA Open Matrix LLIF is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2018-06-25 under 510(k) number K180724. 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 SPIRA Open Matrix LLIF?

SPIRA Open Matrix LLIF is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K180724.

When did SPIRA Open Matrix LLIF receive FDA 510(k) clearance?

SPIRA Open Matrix LLIF received FDA 510(k) clearance on 2018-06-25, under 510(k) number K180724.

Who is the listed applicant for SPIRA Open Matrix LLIF?

The FDA 510(k) record lists Camber Spine Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRA Open Matrix LLIF?

The FDA product code for SPIRA Open Matrix LLIF is MAX.

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Outros registros que listam Camber Spine Technologies, LLC como candidato(a)

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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