FDA 510(k)

Kalitec Navigated Instrument System

K-번호: K232572 · 2023-12-13

신청자Kalitec Direct, LLC Doing Business AS Kalitec Medical

결정일2023-12-13

제품 코드OLO

자문 위원회NE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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Kalitec Navigated Instrument System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OLO)

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