FDA 510(k)

Stryker MP, Mandible, HMMF and MMF AXS Screws

Número K: K231599 · 2023-08-24

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2023-08-24

Código do produtoDZL

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stryker MP, Mandible, HMMF and MMF AXS Screws 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 2023-08-24 under 510(k) number K231599. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Stryker MP, Mandible, HMMF and MMF AXS Screws?

Stryker MP, Mandible, HMMF and MMF AXS Screws is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K231599.

When did Stryker MP, Mandible, HMMF and MMF AXS Screws receive FDA 510(k) clearance?

Stryker MP, Mandible, HMMF and MMF AXS Screws received FDA 510(k) clearance on 2023-08-24, under 510(k) number K231599.

Who is the listed applicant for Stryker MP, Mandible, HMMF and MMF AXS Screws?

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 MP, Mandible, HMMF and MMF AXS Screws?

The FDA product code for Stryker MP, Mandible, HMMF and MMF AXS Screws is DZL.

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Fonte oficial

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