FDA 510(k)

TDM Lumbar Interbody Fusion Cage System

Número K: K221844 · 2022-08-17

Data da decisão2022-08-17

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TDM Lumbar Interbody Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Tdm Co., Ltd.. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K221844. 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 TDM Lumbar Interbody Fusion Cage System?

TDM Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K221844.

When did TDM Lumbar Interbody Fusion Cage System receive FDA 510(k) clearance?

TDM Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2022-08-17, under 510(k) number K221844.

Who is the listed applicant for TDM Lumbar Interbody Fusion Cage System?

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

What is the FDA product code for TDM Lumbar Interbody Fusion Cage System?

The FDA product code for TDM Lumbar Interbody Fusion Cage System is MAX.

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Fonte oficial

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