FDA 510(k)

ICX-Implant System

K-번호: K231566 · 2024-09-05

결정일2024-09-05

제품 코드DZE

자문 위원회DE

결정Substantially Equivalent

기기 요약

ICX-Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medentis Medical GmbH. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K231566. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ICX-Implant System?

ICX-Implant System is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Medentis Medical GmbH. The 510(k) number is K231566.

When did ICX-Implant System receive FDA 510(k) clearance?

ICX-Implant System received FDA 510(k) clearance on 2024-09-05, under 510(k) number K231566.

Who is the listed applicant for ICX-Implant System?

The FDA 510(k) record lists Medentis Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICX-Implant System?

The FDA product code for ICX-Implant System is DZE.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

ICX-Implant System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: DZE)

공식 출처