FDA 510(k)

uCerv Flux™-C 3D Porous Titanium Cervical Interbody

Número K: K241396 · 2024-05-23

Data da decisão2024-05-23

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

uCerv Flux™-C 3D Porous Titanium Cervical Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K241396. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

uCerv Flux™-C 3D Porous Titanium Cervical Interbody is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Ulrich Medical USA, Inc.. The 510(k) number is K241396.

When did uCerv Flux™-C 3D Porous Titanium Cervical Interbody receive FDA 510(k) clearance?

uCerv Flux™-C 3D Porous Titanium Cervical Interbody received FDA 510(k) clearance on 2024-05-23, under 510(k) number K241396.

Who is the listed applicant for uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

The FDA 510(k) record lists Ulrich Medical USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

The FDA product code for uCerv Flux™-C 3D Porous Titanium Cervical Interbody is ODP.

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Fonte oficial

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