FDA 510(k)

Expandable Lumbar Fusion Cage (Type I,Type II)

Número K: K232069 · 2023-11-29

RequerenteShanghai Reach Medical Instrument Co, Ltd.

Data da decisão2023-11-29

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Expandable Lumbar Fusion Cage (Type I,Type II) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Reach Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K232069. 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 Expandable Lumbar Fusion Cage (Type I,Type II)?

Expandable Lumbar Fusion Cage (Type I,Type II) is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Shanghai Reach Medical Instrument Co, Ltd.. The 510(k) number is K232069.

When did Expandable Lumbar Fusion Cage (Type I,Type II) receive FDA 510(k) clearance?

Expandable Lumbar Fusion Cage (Type I,Type II) received FDA 510(k) clearance on 2023-11-29, under 510(k) number K232069.

Who is the listed applicant for Expandable Lumbar Fusion Cage (Type I,Type II)?

The FDA 510(k) record lists Shanghai Reach Medical Instrument Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Expandable Lumbar Fusion Cage (Type I,Type II)?

The FDA product code for Expandable Lumbar Fusion Cage (Type I,Type II) is MAX.

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Fonte oficial

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