FDA 510(k)

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System

Número K: K173811 · 2018-03-15

Data da decisão2018-03-15

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K173811. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System?

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is In2bones Sas. The 510(k) number is K173811.

When did TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System receive FDA 510(k) clearance?

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System received FDA 510(k) clearance on 2018-03-15, under 510(k) number K173811.

Who is the listed applicant for TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System?

The FDA product code for TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System is HSB.

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Fonte oficial

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