FDA 510(k)

BluEX Lumbar Expandable Cage System

Número K: K242829 · 2024-10-23

Data da decisão2024-10-23

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BluEX Lumbar Expandable Cage System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2024-10-23 under 510(k) number K242829. 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 BluEX Lumbar Expandable Cage System?

BluEX Lumbar Expandable Cage System is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K242829.

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

BluEX Lumbar Expandable Cage System received FDA 510(k) clearance on 2024-10-23, under 510(k) number K242829.

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

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Fonte oficial

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