FDA 510(k)

SPIRA® Anterior Lumbar Spacers

K-번호: K234077 · 2024-07-12

결정일2024-07-12

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

SPIRA® Anterior Lumbar Spacers is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K234077. 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 SPIRA® Anterior Lumbar Spacers?

SPIRA® Anterior Lumbar Spacers is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Camber Spine Technologies. The 510(k) number is K234077.

When did SPIRA® Anterior Lumbar Spacers receive FDA 510(k) clearance?

SPIRA® Anterior Lumbar Spacers received FDA 510(k) clearance on 2024-07-12, under 510(k) number K234077.

Who is the listed applicant for SPIRA® Anterior Lumbar Spacers?

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

What is the FDA product code for SPIRA® Anterior Lumbar Spacers?

The FDA product code for SPIRA® Anterior Lumbar Spacers is MAX.

Camber Spine Technologies를 신청인으로 등재한 기타 기록

K233972Camber Sacroiliac (SI) Fixation System K230942SPIRA® Posterior Lumbar Spacers K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)K223837SPIRA®-C Integrated Fixation System K220038Camber Spine Navigation System K193153SPIRA-C Integrated Fixation System

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