FDA 510(k)

Kalitec导航器械系统

K号: K232572 · 2023-12-13

申请人Kalitec Direct, LLC Doing Business AS Kalitec Medical

决定日期2023-12-13

产品代码OLO

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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Kalitec导航器械系统

器械摘要

常见问题

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