FDA 510(k)

SPIRA® Posterior Lumbar Spacers

Número K: K230942 · 2023-07-11

Data da decisão2023-07-11

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPIRA® Posterior Lumbar Spacers is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2023-07-11 under 510(k) number K230942. 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® Posterior Lumbar Spacers?

SPIRA® Posterior Lumbar Spacers is a medical device that received FDA 510(k) clearance on 2023-07-11. The listed applicant is Camber Spine Technologies. The 510(k) number is K230942.

When did SPIRA® Posterior Lumbar Spacers receive FDA 510(k) clearance?

SPIRA® Posterior Lumbar Spacers received FDA 510(k) clearance on 2023-07-11, under 510(k) number K230942.

Who is the listed applicant for SPIRA® Posterior Lumbar Spacers?

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

What is the FDA product code for SPIRA® Posterior Lumbar Spacers?

The FDA product code for SPIRA® Posterior Lumbar Spacers is MAX.

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

K234077SPIRA® Anterior Lumbar Spacers K233972Camber Sacroiliac (SI) Fixation System K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)K223837SPIRA®-C Integrated Fixation System K220038Camber Spine Navigation System K193153SPIRA-C Integrated Fixation System

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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