FDA 510(k)

고명脊椎 3D 루밍 인터빗 브릿지 합성 시스템

K-번호: K230219 · 2023-05-16

결정일2023-05-16

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

Eminent Spine 3D Lumbar Interbody Fusion Systems is the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine, LLC. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K230219. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Eminent Spine 3D Lumbar Interbody Fusion Systems?

Eminent Spine 3D Lumbar Interbody Fusion Systems is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Eminent Spine, LLC. The 510(k) number is K230219.

When did Eminent Spine 3D Lumbar Interbody Fusion Systems receive FDA 510(k) clearance?

Eminent Spine 3D Lumbar Interbody Fusion Systems received FDA 510(k) clearance on 2023-05-16, under 510(k) number K230219.

Who is the listed applicant for Eminent Spine 3D Lumbar Interbody Fusion Systems?

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

What is the FDA product code for Eminent Spine 3D Lumbar Interbody Fusion Systems?

The FDA product code for Eminent Spine 3D Lumbar Interbody Fusion Systems is MAX.

Eminent Spine, LLC를 신청인으로 등재한 기타 기록

K240505고명脊椎 SI 스크루 시스템 K212853목좌립체 시스템 K201979목 부상 시스템

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