FDA 510(k)

Kalitec Navigated Instrument System

Número K: K232572 · 2023-12-13

RequerenteKalitec Direct, LLC Doing Business AS Kalitec Medical

Data da decisão2023-12-13

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kalitec Navigated Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC Doing Business AS Kalitec Medical. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K232572. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kalitec Navigated Instrument System?

Kalitec Navigated Instrument System is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Kalitec Direct, LLC Doing Business AS Kalitec Medical. The 510(k) number is K232572.

When did Kalitec Navigated Instrument System receive FDA 510(k) clearance?

Kalitec Navigated Instrument System received FDA 510(k) clearance on 2023-12-13, under 510(k) number K232572.

Who is the listed applicant for Kalitec Navigated Instrument System?

The FDA 510(k) record lists Kalitec Direct, LLC Doing Business AS Kalitec Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kalitec Navigated Instrument System?

The FDA product code for Kalitec Navigated Instrument System is OLO.

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