FDA 510(k)

uCerv Flux-C 3D Porous Titanium Cervical Interbody

Número K: K220696 · 2022-08-19

Data da decisão2022-08-19

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. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220696. 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 2022-08-19. The listed applicant is Ulrich Medical USA. The 510(k) number is K220696.

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 2022-08-19, under 510(k) number K220696.

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

The FDA 510(k) record lists Ulrich Medical USA 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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