FDA 510(k)

XYPAN Expandable Lumbar Cage System

Número K: K203531 · 2021-01-29

Data da decisão2021-01-29

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

XYPAN Expandable Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Spine, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K203531. 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 XYPAN Expandable Lumbar Cage System?

XYPAN Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Aegis Spine, Inc.. The 510(k) number is K203531.

When did XYPAN Expandable Lumbar Cage System receive FDA 510(k) clearance?

XYPAN Expandable Lumbar Cage System received FDA 510(k) clearance on 2021-01-29, under 510(k) number K203531.

Who is the listed applicant for XYPAN Expandable Lumbar Cage System?

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

What is the FDA product code for XYPAN Expandable Lumbar Cage System?

The FDA product code for XYPAN Expandable Lumbar Cage System is MAX.

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Outros registros que listam Aegis Spine, Inc. como candidato(a)

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Fonte oficial

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