FDA 510(k)

MEDPOR Customized Implant Kit

Número K: K254233 · 2026-03-12

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2026-03-12

Código do produtoFWP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MEDPOR 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 2026-03-12 under 510(k) number K254233. 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 MEDPOR Customized Implant Kit?

MEDPOR Customized Implant Kit is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K254233.

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

MEDPOR Customized Implant Kit received FDA 510(k) clearance on 2026-03-12, under 510(k) number K254233.

Who is the listed applicant for MEDPOR 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 MEDPOR Customized Implant Kit?

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

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Fonte oficial

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