FDA 510(k)

CoLink® Mini Plating System

Número K: K191535 · 2019-07-29

Data da decisão2019-07-29

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoLink® Mini 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 2019-07-29 under 510(k) number K191535. 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® Mini Plating System?

CoLink® Mini Plating System is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is In2bones USA, LLC. The 510(k) number is K191535.

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

CoLink® Mini Plating System received FDA 510(k) clearance on 2019-07-29, under 510(k) number K191535.

Who is the listed applicant for CoLink® Mini 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® Mini Plating System?

The FDA product code for CoLink® Mini Plating System is HRS.

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Fonte oficial

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