FDA 510(k)

PRO Plating System, Stryker Trauma Pelvic Set (Matta)

Número K: K223772 · 2023-04-07

Data da decisão2023-04-07

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRO Plating System, Stryker Trauma Pelvic Set (Matta) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223772. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

PRO Plating System, Stryker Trauma Pelvic Set (Matta) is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Stryker GmbH. The 510(k) number is K223772.

When did PRO Plating System, Stryker Trauma Pelvic Set (Matta) receive FDA 510(k) clearance?

PRO Plating System, Stryker Trauma Pelvic Set (Matta) received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223772.

Who is the listed applicant for PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

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

What is the FDA product code for PRO Plating System, Stryker Trauma Pelvic Set (Matta)?

The FDA product code for PRO Plating System, Stryker Trauma Pelvic Set (Matta) is HRS.

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Fonte oficial

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