FDA 510(k)

Stryker CMF MEDPOR Priority Customized Implant Kit

Número K: K191916 · 2019-08-15

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2019-08-15

Código do produtoFWP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stryker CMF MEDPOR Priority Customized Implant Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K191916. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Stryker CMF MEDPOR Priority Customized Implant Kit?

Stryker CMF MEDPOR Priority Customized Implant Kit is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K191916.

When did Stryker CMF MEDPOR Priority Customized Implant Kit receive FDA 510(k) clearance?

Stryker CMF MEDPOR Priority Customized Implant Kit received FDA 510(k) clearance on 2019-08-15, under 510(k) number K191916.

Who is the listed applicant for Stryker CMF MEDPOR Priority Customized Implant Kit?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker CMF MEDPOR Priority Customized Implant Kit?

The FDA product code for Stryker CMF MEDPOR Priority Customized Implant Kit is FWP.

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Ver todos os 19 dispositivos →

Dispositivos Relacionados (Código: FWP)

K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG K232593FITme Customized Silicone ImplantKeosan Trading Co.K200610Customized Contour ImplantImplantech Associates, Inc.K191130Customized Contour ImplantImplantech Associates, Inc.K153508Stryker CMF MEDPOR Customized ImplantStryker K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC

Fonte oficial

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