FDA 510(k)

Highness Implant System

K-번호: K240383 · 2024-10-31

결정일2024-10-31

제품 코드DZE

자문 위원회DE

결정Substantially Equivalent

기기 요약

Highness Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Highness Co., Ltd.. It received FDA 510(k) clearance on 2024-10-31 under 510(k) number K240383. 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 Highness Implant System?

Highness Implant System is a medical device that received FDA 510(k) clearance on 2024-10-31. The listed applicant is Highness Co., Ltd.. The 510(k) number is K240383.

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

Highness Implant System received FDA 510(k) clearance on 2024-10-31, under 510(k) number K240383.

Who is the listed applicant for Highness Implant System?

The FDA 510(k) record lists Highness Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Highness Implant System?

The FDA product code for Highness Implant System is DZE.

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Highness Implant System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: DZE)

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