FDA 510(k)

Austin Miller Large External Fixation System

Número K: K181528 · 2019-02-28

Data da decisão2019-02-28

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Austin Miller Large External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Austin Miller Trauma, LLC. It received FDA 510(k) clearance on 2019-02-28 under 510(k) number K181528. 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 Austin Miller Large External Fixation System?

Austin Miller Large External Fixation System is a medical device that received FDA 510(k) clearance on 2019-02-28. The listed applicant is Austin Miller Trauma, LLC. The 510(k) number is K181528.

When did Austin Miller Large External Fixation System receive FDA 510(k) clearance?

Austin Miller Large External Fixation System received FDA 510(k) clearance on 2019-02-28, under 510(k) number K181528.

Who is the listed applicant for Austin Miller Large External Fixation System?

The FDA 510(k) record lists Austin Miller Trauma, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Austin Miller Large External Fixation System?

The FDA product code for Austin Miller Large External Fixation System is KTT.

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