FDA 510(k)

RIGEL 3DR Anterior Cervical Interbody Fusion System

K-번호: K200685 · 2020-06-11

결정일2020-06-11

제품 코드ODP

자문 위원회OR

결정Substantially Equivalent

기기 요약

RIGEL 3DR Anterior Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2020-06-11 under 510(k) number K200685. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the RIGEL 3DR Anterior Cervical Interbody Fusion System?

RIGEL 3DR Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-06-11. The listed applicant is MiRus, LLC. The 510(k) number is K200685.

When did RIGEL 3DR Anterior Cervical Interbody Fusion System receive FDA 510(k) clearance?

RIGEL 3DR Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2020-06-11, under 510(k) number K200685.

Who is the listed applicant for RIGEL 3DR Anterior Cervical Interbody Fusion System?

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

What is the FDA product code for RIGEL 3DR Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL 3DR Anterior Cervical Interbody Fusion System is ODP.

MiRus, LLC를 신청인으로 등재한 기타 기록

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