FDA 510(k)

AccelFix Lumbar Expandable Cage System

Número K: K231680 · 2023-08-24

Data da decisão2023-08-24

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AccelFix 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 2023-08-24 under 510(k) number K231680. 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 AccelFix Lumbar Expandable Cage System?

AccelFix Lumbar Expandable Cage System is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K231680.

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

AccelFix Lumbar Expandable Cage System received FDA 510(k) clearance on 2023-08-24, under 510(k) number K231680.

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

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

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Outros registros que listam L&K BIOMED Co., Ltd. como candidato(a)

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Fonte oficial

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