FDA 510(k)

T-Rex Standalone ALIF

Número K: K170855 · 2017-09-07

Data da decisão2017-09-07

Código do produtoOVD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

T-Rex Standalone ALIF is the device name listed in this FDA 510(k) record. The listed applicant is Siats, LLC. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K170855. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the T-Rex Standalone ALIF?

T-Rex Standalone ALIF is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Siats, LLC. The 510(k) number is K170855.

When did T-Rex Standalone ALIF receive FDA 510(k) clearance?

T-Rex Standalone ALIF received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170855.

Who is the listed applicant for T-Rex Standalone ALIF?

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

What is the FDA product code for T-Rex Standalone ALIF?

The FDA product code for T-Rex Standalone ALIF is OVD.

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