FDA 510(k)

restor3d TiDAL Lumbar Interbody Fusion Device

Número K: K220523 · 2022-06-17

Data da decisão2022-06-17

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

restor3d TiDAL Lumbar Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2022-06-17 under 510(k) number K220523. 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 restor3d TiDAL Lumbar Interbody Fusion Device?

restor3d TiDAL Lumbar Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Restor3D. The 510(k) number is K220523.

When did restor3d TiDAL Lumbar Interbody Fusion Device receive FDA 510(k) clearance?

restor3d TiDAL Lumbar Interbody Fusion Device received FDA 510(k) clearance on 2022-06-17, under 510(k) number K220523.

Who is the listed applicant for restor3d TiDAL Lumbar Interbody Fusion Device?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for restor3d TiDAL Lumbar Interbody Fusion Device?

The FDA product code for restor3d TiDAL Lumbar Interbody Fusion Device is MAX.

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Fonte oficial

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