FDA 510(k)

CoLink NeoFuse Plating System

Número K: K213069 · 2021-12-13

Data da decisão2021-12-13

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoLink NeoFuse Plating System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K213069. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CoLink NeoFuse Plating System?

CoLink NeoFuse Plating System is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is In2bones USA, LLC. The 510(k) number is K213069.

When did CoLink NeoFuse Plating System receive FDA 510(k) clearance?

CoLink NeoFuse Plating System received FDA 510(k) clearance on 2021-12-13, under 510(k) number K213069.

Who is the listed applicant for CoLink NeoFuse Plating System?

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

What is the FDA product code for CoLink NeoFuse Plating System?

The FDA product code for CoLink NeoFuse Plating System is HRS.

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Fonte oficial

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