FDA 510(k)

Reprocessed Stryker External Fixation Devices

Número K: K153415 · 2016-01-13

RequerenteStryker Sustainability Solutions

Data da decisão2016-01-13

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed Stryker External Fixation Devices is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153415. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed Stryker External Fixation Devices?

Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K153415.

When did Reprocessed Stryker External Fixation Devices receive FDA 510(k) clearance?

Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153415.

Who is the listed applicant for Reprocessed Stryker External Fixation Devices?

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

What is the FDA product code for Reprocessed Stryker External Fixation Devices?

The FDA product code for Reprocessed Stryker External Fixation Devices is KTT.

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Fonte oficial

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