FDA 510(k)

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System

Número K: K193067 · 2020-06-08

Data da decisão2020-06-08

Código do produtoHSN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2020-06-08 under 510(k) number K193067. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is a medical device that received FDA 510(k) clearance on 2020-06-08. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K193067.

When did The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System receive FDA 510(k) clearance?

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System received FDA 510(k) clearance on 2020-06-08, under 510(k) number K193067.

Who is the listed applicant for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

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

What is the FDA product code for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System?

The FDA product code for The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System is HSN.

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Fonte oficial

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